Trends and Outcomes of Twin Births in Southwest Nigeria: A 14-Year Retrospective Cohort Study.

Background and objectives: The study aimed to analyze the prevalence, trends, and outcomes of twin pregnancies in Ile-Ife, Nigeria, over two distinct periods. Materials and methods: This research, based on a 14-year retrospective cohort study, scrutinized twin births occurring in two-time frames: recent years (2012-2018; Period II) and the recent past (2005-2011; Period I) at a University Teaching Hospital in Ile-Ife, Nigeria. The inclusion criteria were limited to twin births, excluding singleton and higher-order gestations. Outcomes were evaluated based on several parameters, including mode of delivery, birth weights, fetal gender combinations, APGAR scores, perinatal mortality, and maternal complications. Data analysis was conducted using the 26th version of Statistical Package for the Social Science, with a significance threshold of p < 0.05. Results: The study documented a stable prevalence of twin gestations, registering at 20.7 per 1,000 births without a significant discrepancy between the two time periods (21.7‰ versus 19.7‰; p = 0.699). Individuals from the Yoruba tribe predominantly featured in both cohorts, showing no considerable variation between the two time periods [83 (95.4) vs. 120 (99.2); p-value = 0.116]). The data exhibited recurrent instances of caesarean delivery (65.6% vs. 50.2%, p = 0.119), vertex-vertex presentation (38.0% vs. 44.7%, p = 0.352), and differing sex combinations (33.3% vs. 38.0%, p = 0.722) across both time frames. Twin II neonates born through Caesarean section were more frequently admitted to neonatal intensive care units than Twin I (5.1% versus 4.6%; p = 0.001). The recent years witnessed a surge in preterm labor complications, notably higher than the earlier period (17.1% versus 7.8%; p = 0.008). Conclusion: The prevalence of twin births in Ile-Ife, Nigeria, demonstrates a fluctuating decline. To comprehensively understand the dynamics of twin births in the region, there is a pressing need for expansive, community-centric research in southwest Nigeria.

Intravenous versus intramuscular oxytocin injection for preventing uterine atonic primary postpartum haemorrhage in third stage of labour: A double-blind randomised controlled trial.

Objectives: To compare the efficacy and safety of intravenous and intramuscular oxytocin in preventing atonic primary postpartum haemorrhage in the third stage of labour. Methods: A double-blind randomised clinical study on consenting women without risk factors for primary postpartum haemorrhage in labour at term. Two hundred and thirty-two women were randomly allotted into intravenous (n = 115) and intramuscular (n = 117) oxytocin groups in the active management of the third stage of labour. All participants received 10 IU of oxytocin, either IV or IM, and 1 ml of water for injection as a placebo via a route alternate to that of administration of oxytocin within 1 min of the baby's delivery. The primary outcome measures were mean postpartum blood loss and haematocrit change. Trial Registration No.: PACTR201902721929705. Results: The baseline socio-demographic and clinical characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups with regards to the mean postpartum blood loss (254.17 ± 34.85 ml versus 249.4 ± 39.88 ml; p = 0.210), haematocrit change (2.4 (0.8%) versus 2.1 (0.6%); p = 0.412) or adverse effects (p > 0.05). However, the use of additional uterotonics was significantly higher in the intravenous group (25 (21.73%) versus 17 (14.53%); p = 0.032). Conclusion: Although oxytocin in both study groups showed similar efficacy in terms of preventing atonic primary postpartum haemorrhage, participants who received intravenous oxytocin were more likely to require additional uterotonics to reduce their likelihood of having an atonic primary postpartum haemorrhage. However, both routes have similar side effect profiles.

The impact of COVID-19 on the birth rate in Nigeria: a report from population-based registries.

Background and objectives: Coronavirus disease 2019 (COVID-19) is a pandemic that has become a major source of morbidity and mortality worldwide, affecting the physical and mental health of individuals influencing reproduction. Despite the threat, it poses to maternal health in sub-Saharan Africa and Nigeria, there is little or no data on the impact it has on fertility, conception, gestation and birth. To compare the birth rate between pre-COVID and COVID times using selected months of the year. Materials and methods: This was a secondary analysis of cross-sectional analytical study data from the birth registries of three tertiary hospitals, comparing two years [2019 (Pre-COVID)] versus [2020 (COVID era)] using three months of the year (October to December). The data relied upon was obtained from birth registries in three busy maternity clinics all within tertiary hospitals in South-East Nigeria and we aimed at discussing the potential impacts of COVID-19 on fertility in Nigeria. The secondary outcome measures were; mode of delivery, booking status of the participants, maternal age and occupation. Results: There was a significant decrease in tertiary-hospital based birth rate by 92 births (P = 0.0009; 95% CI: -16.0519 to -4.1481) among mothers in all the three hospitals in 2020 during the COVID period (post lockdown months) of October to December. There was a significant difference in the mode of delivery for mothers (P = 0.0096) with a 95% confidence interval of 1.0664 to 1.5916, as more gave birth through vaginal delivery during the 2020 COVID-19 period than pre-COVID-19. Conclusion: Tertiary-hospital based birth rates were reduced during the pandemic. Our multi-centre study extrapolated on possible factors that may have played a role in this decline in their birth rate, which includes but is not limited to; decreased access to hospital care due to the total lockdowns/curfews and worsening inflation and economic recession in the country.

Efficacy and safety of Mojeaga remedy in combination with conventional oral iron therapy for correcting anemia in obstetric population: A phase II randomized pilot clinical trial.

BACKGROUND: To our knowledge, there is no prior randomized trial on the efficacy of Mojeaga remedy (a special blend of Alchornea cordifolia, Pennisetum glaucum and Sorghum bicolor extracts) when co-administered with standard-of-care for correction of anemia in obstetrics practice. This study determined the efficacy, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetric population. METHODS: A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga group) for 2 weeks or conventional iron therapy alone without Mojeaga (standard-of-care group) for 2 weeks. Repeat hematocrit level were done 2 weeks post-initial therapy. Primary outcome measures were changes in hematocrit level and median hematocrit level at two weeks post therapy. Maternal adverse events and neonatal outcomes (birth anomalies, low birthweight, preterm rupture of membranes and preterm labor) were considered the safety outcome measures. Analysis was by intention-to-treat. RESULTS: Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.00±4.00%;p<0.001) and median hematocrit values (31.00±2.00% vs 27.00±3.00%;p<0.001) were significantly higher in the Mojeaga group. There were no treatment-related serious adverse events, congenital anomalies or deaths in the Mojeaga group and incidence of other neonatal outcomes were similar (p>0.05). CONCLUSION: Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes. CLINICAL TRIAL REGISTRATION: www.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).

A randomised control trial on oral dydrogesterone versus micronized vaginal progesterone pessary for luteal phase support in in vitro fertilization cycles.

This study aimed to evaluate the pregnancy rates, adverse reactions, and medication costs of two luteal phase support regimens: oral dydrogesterone and micronized vaginal progesterone (MVP) pessary in in vitro fertilization cycles. A randomized open-label trial with participants randomly assigned to either 400 mg MVP twice daily or 10 mg dydrogesterone three times daily. The primary endpoints were pregnancy rates, and the secondary endpoints included tolerance, miscarriage rates, and medication cost. Per-protocol principle analysis was performed. The baseline characteristics of the 162 participants were similar. Dydrogesterone had statistically similar (p>0.05) positive pregnancy test rates fifteen days post embryo transfer (35.8% vs. 32.7%), clinical pregnancy rates at the gestational age of 6 weeks (32.1% vs. 28.8%), ongoing pregnancy rates (26.4% vs. 23.1%) and miscarriage rates at 14 weeks of gestation (9.2% vs. 9.4%) and safety profile to MVP. Dydrogesterone was better tolerated as vaginal itching was significantly more prevalent in the MVP arm (p=0.008). Dydrogesterone is significantly less expensive than MVP pessary. Oral dydrogesterone and MVP pessary had similar pregnancy rates and adverse effects. Dydrogesterone appears more user-friendly and less expensive in cases of luteal-phase support in in vitro fertilization cycles.

A 7-year review of medical admission profile for clinical diseases in an intensive care unit of a low-resource setting.

Objective: Various patients needing organ or systemic support and close monitoring are routinely managed in the intensive care unit. This includes patients that emanate from various sources, like the trauma unit, emergency department, inpatient wards, and post-anesthesia care unit. Admissions into the intensive care unit due to medical conditions have not been analyzed in our environment to determine the common indications and the outcome. We aimed to determine the pattern of medical admissions and outcomes in the intensive care unit. Method: A retrospective study of all patients admitted to the intensive care unit of Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria, from January 1, 2014 to December 31, 2020, with medical diagnosis was conducted. Data were retrieved from the intensive care unit admission and discharge registers and analyzed using the Statistical Package for Social Sciences (SPSS) Version 20 (IBM Corp., Chicago, Illinois, USA). Results: Eighty-nine medical patients were admitted, which accounted for 7.63% of the total intensive care unit admissions of 1167 patients during the period, with a preponderance of males (57.3%). The most common medical condition for intensive care unit admission (31.5%) was a cerebrovascular accident. The mean length of stay was found to be 5.13 ± 3.42 days. Mortality following medical intensive care unit admission was 56.18%, which contributed to about 11.4% of the total ICU mortality. Conclusion: When compared to all other reasons for admission to a general intensive care unit, medical conditions account for a small percentage. The most frequent illness was a cerebrovascular accident.

Comparison of Pregnancy Outcomes of History-Indicated and Ultrasound-Indicated Cervical Cerclage: A Retrospective Cohort Study.

Background: Cervical cerclage is the procedure of choice for preventing preterm delivery due to cervical insufficiency. The indication for its application may be based on the woman's reproductive history, findings at ultrasound, or clinical findings on vaginal examination. Pregnancy outcomes from these indications are variable according to the available literature. Objective: To compare the effectiveness and reproductive outcomes (miscarriage, preterm birth rates, and birth weights) of McDonald's cervical cerclage after history-indicated and ultrasound-indicated cervical cerclage in pregnant women. Methods: The retrospective cohort study was conducted at Life International Hospital Awka, Nigeria and Life Specialist Hospital Nnewi, Nigeria. Pregnant women, who had a McDonald's cervical cerclage performed due to either history or ultrasound indication between January 1, 2011, and December 31, 2020, were included in the study. Women with multiple pregnancies and those with physical examination-indicated or emergency cerclages were excluded. The main outcome measures included the prevalence of cervical cerclage, miscarriage, and preterm delivery rates. Outcomes were compared between groups with the chi-square test, Fisher's exact test, or Student's t test. p value of < 0.5 was set as significant value. Results: Overall, during the study period, 5392 deliveries occurred in the study sites, of which 103 women had a history-indicated or ultrasound-indicated cervical cerclage. This resulted in a 1.91% prevalence rate for history-indicated and ultrasound-indicated cervical cerclage. Of these, 68 (66%) had history indicated, while 35 (34%) had ultrasound-indicated cerclage. There was no difference in the sociodemographic characteristics of both groups. Both groups had similar miscarriage rates: 1.18 in 1000 and 1.04 in 1000 deliveries, respectively (RR 1.160, 95% CI: 0.3824 to 3.5186, p = 0.793). There was more preterm delivery in history-indicated cerclage than ultrasound-indicated cervical cerclage (26.50% vs. 17.10%; p = 0.292), though the difference was not statistically significant. The ultrasound group had a higher average birthweight than the history group (2.67 ± 0.99 vs. 2.53 ± 0.74). However, this difference was not statistically significant. Conclusion: The effectiveness and reproductive outcomes (miscarriage, preterm birth rates, and birth weights) of pregnant women with cervical cerclage due to history-indicated and ultrasound-indicated cervical cerclage appear similar. When needed, cervical cerclage should be freely applied for cervical insufficiency, irrespective of the type of indication.

Conception following successful repair of two previous failed attempts at repair of partial transverse vaginal septum diagnosed after marital union: A case report.

Transverse vaginal septum is a congenital anomaly in which a membrane obstructs the vagina. This can be partial or complete in type. Although rare, it presents peculiar challenges in symptomatology, diagnosis, and ultimate management. To our knowledge, we are the first to report a shortest vaginoplasty-conception interval following successful repair of previously failed repair of partial transverse vaginal septum. A 28-year-old Nigerian married nulliparous lady who presented to us with history of inability of penile-vaginal penetration with the presence of normal menstrual flow after two previous failed attempts at repair. She had a vaginoplasty with placement of a vaginal mold to prevent stenosis. She was subsequently able to have successful sexual intercourse and achieved pregnancy after 2 months, without recurrence of vaginal stenosis. When transverse vaginal septum is encountered in a married nullipara, a thorough clinical evaluation of the viability and feasibility of a vaginoplasty should be made during the first surgery. If repeated failed repair occurs, as in our case, we recommend meticulous and experienced surgical attention from the outset. The originality in this report lies in the very short period between repair and successful conception. Thus, we obtained satisfactory short-term clinical outcome of successful conception at the 2 months follow-up.

Correlation between hysterosalpingography diagnosis and final hysterolaparoscopy with dye-test diagnosis in women with utero-tubal infertility: A cross-sectional study of the implication for which test should be the first-line investigation.

Objective: To assess the accuracy of hysterosalpingography in diagnosis of uterine and/or tubal factor infertility, using hysterolaparoscopy with dye test as the gold standard with an implication for which test should be the first-line investigation. Methods: A prospective cross-sectional study of 96 women who underwent hysterosalpingography and hysterolaparoscopy with dye test. All women within reproductive age group with utero-tubal infertility who underwent both hysterosalpingography and hysterolaparoscopy with dye-test procedure were included. The outcome measures were proportions of tubal blockage and intrauterine pathology. Individual and overall mean accuracy were calculated for hysterosalpingography, using hysterolaparoscopy with dye test as the gold standard. Patient had procedure of hysterosalpingography first and both laparoscopic surgeons and patients were blinded to the outcome of hysterolaparoscopy with dye test until analysis. Statistical significance was set at p < 0.05. Results: Overall, 128 women were assessed for eligibility while 96 women finally completed the study. Hysterosalpingography demonstrated diagnostic accuracy of 77.8% (p < 0.001), 76.3% (p < 0.001) and 78.3% (p < 0.001) for right, left and bilateral tubal blockage, respectively. Overall accuracy of hysterosalpingography tubal factor assessment was 77.4 ± 0.8% (95% confidence interval = 76.5% to 78.4%). Hysterosalpingography showed an accuracy of 85.7%, 86.6% and 76.7% for right, left and bilateral hydrosalpinx, respectively, given overall diagnostic accuracy of 83.0 ± 5.1% (95% confidence interval = 77.9% to 88.1%). Overall accuracy of hysterosalpingography in diagnosing intrauterine pathology was 68.5 ± 9.8% (95% confidence interval = 53.9% to 83.1%). Conclusion: Hysterosalpingography detects tubal blockade and intrauterine pathology poorly compared to hysterolaparoscopy with dye test. Hysterosalpingography may face unpredictable clinical situations biased by technological error, leading to unsuccessful evaluation and uncertain diagnosis. Although the cost-effectiveness, risk of surgery or anaesthesia flaws hysterolaparoscopy with dye test. Hysterosalpingography should not be the first-line utero-tubal assessment tool rather hysterolaparoscopy with dye test.

Roberts syndrome with tetraphocomelia: A case report and literature review.

Roberts syndrome is a rare genetic disorder characterized by symmetrical reductive limb malformation and craniofacial abnormalities. It is caused by mutation in the "Establishment of cohesion 1 homolog 2" genes, resulting in the loss of acetyltransferase activities and manifesting as premature centromere separation in metaphase chromosomes. The affected individual grows slowly during pregnancy and after birth with associated mild to severe intellectual impairment. We present a 35-year-old multiparous Nigerian lady who had emergency cesarean section at 35 weeks of gestation following abruptio placentae with a live fetus. The baby had poor Apgar score at birth and died shortly afterward. Tetraphocomelia was detected on prenatal ultrasound done at about 24 weeks of gestation with other features sonographically normal. However, clinical diagnosis of severe variant of Roberts syndrome with tetraphocomelia, growth restriction, and craniofacial abnormalities were noted at birth. This case exhibits a very rare variant of Roberts syndrome with tetraphocomelia, intrauterine growth restriction, and craniofacial abnormalities. It also highlights the crucial role of detailed clinical examination and the inherent challenges in making cytogenetic diagnosis in low-income countries.

Cesarean section rate and outcomes during and before the first wave of COVID-19 pandemic.

Objectives: The objective of the study was to assess how the current COVID-19 pandemic has affected cesarean section (C-section) rates, indications, and peripartum outcomes. Methods: This was a retrospective cross-sectional study that compared a 3-month rates of and indications for C-sections at three tertiary health care institutions in Nigeria before (October 2019-December 2019) and during the first wave of COVID-19 pandemic (March 2020-May 2020). Primary outcomes were C-section rate and indications between the two periods. Data were analyzed using SPSS 26.0 IBM Corporation. Rates and odds ratios with 95% confidence intervals were used to quantify indications and peripartum outcomes and statistical significance was accepted when p value was <0.05. Results: The baseline characteristics of the two groups were similar. The C-section rate during the COVID-19 period was significantly less than the period prior to the pandemic (237/580, 40.0% vs 390/833, 46.8%; p = 0.027). The rates of postdatism (odds ratio = 1.47, 95% confidence interval = 1.05-2.05, p = 0.022), fetal distress (odds ratio = 3.06, 95% confidence interval = 1.55-6.06, p = 0.017), emergency C-section (odds ratio = 1.43, 95% confidence interval = 1.01-2.05, p = 0.042), and anemia (odds ratio = 1.84, 95% confidence interval = 1.12-3.03, p = 0.016) were significantly higher during the pandemic than prepandemic. Conclusion: The overall C-section rate during the first wave of COVID-19 was significantly lower than the prepandemic period. There were higher rates of postdatism, fetal distress, emergency C-section, and postpartum anemia. Further studies on this changing C-section trend during the pandemic are needed.

'Gift with a price tag': Nigerian egg donors' knowledge, experiences and motivations.

Research around the world has indicated that the demand for egg donation has grown considerably among young females. This study qualitatively examines the knowledge, experiences, and motivations of young egg donors at a Nigerian health facility. In-depth interviews were conducted in Igbo and English with consenting thirty-one egg donors attending a fertil-ity clinic in Anambra State, south-eastern Nigeria. Data were collected and analysed to generate themes with the aid of NVivo 10 software. Three themes were identified from the participants' motivations and include (a) monetary (93.6%), (b) altruistic (3.2%), and (c) both monetary and altruistic reasons (3.2%). Findings highlighted that the differences were based on a variety of reasons in Nigeria. All the participants were literate and single, and the majority received payment. The majority (77.4%) of those who received payment mentioned that the payment was not worth the donation program. The participants preferred to be anonymous because they had not discussed their donation with their family members, and the non-acceptance of egg donation program by the Nigerian society. Given that the market for egg donation has become a common method of infertility management in Nigeria, our findings have important implications for practices, policy actions, and future research.

A double-blind placebo controlled trial on effectiveness of prophylactic dexamethasone for preventing post- dural puncture headache after spinal anesthesia for cesarean section.

AIM: To determine the effect of dexamethasone in reducing post-dural puncture headache (PDPH) after spinal anesthesia for cesarean section (CS). METHODS: A double blind placebo controlled randomized trial of parturients undergoing CS under spinal anesthesia was conducted. Participants (n = 192) were randomly (1:1 ratio) given either 2mls (8 mg) of dexamethasone (n = 96) intravenously or 2mls of normal saline (n = 96) intravenously as placebo after clamping the umbilical cord. Visual analogue scale was used to assess the incidence and severity of PDPH on the first and fourth post-operative days. The primary outcome measure was incidence of PDPH while the secondary outcome measure was incidence of nausea and vomiting. Analysis was by intention-to-treat. RESULTS: Baseline socio-demographic and clinical variables were similar between the two groups and none of the women was lost to follow up. The incidence of PDPH (8.3% vs 25.0%; p = .002) and nausea (11.5% vs 25.0%; p = .015) were significantly lower in dexamethasone group. The severity of headache in the control groups were statistically higher on the first (p < .001) and fourth (p < .001) post-operative days. . CONCLUSION: Prophylactic dexamethasone reduces the incidence and severity of PDPH on both the first and fourth post-operative day after spinal anesthesia for CS. There was also an improvement on the incidence of nausea on the dexamethasone group compared to control.

Delayed presentation of giant uterine fibroids in a Nigerian private specialist health facility.

Giant uterine fibroids (leiomyoma or myomas) which are fibroid masses greater than 11.4 kg are very rare. Although benign in nature, it may present with symptoms that impact negatively on the quality of life and health of the patient and impose greater management challenges. We present two cases of giant uterine fibroids that were successfully managed in a private specialist hospital without complications. Case 1 was a 38-year-old nulliparous Nigerian woman who presented with giant uterine fibroids (11.6 kg) who initially had delay of surgery due to fear that after surgery she may lose her "womb" or not be able to conceive after the operation. Later, she had successful open abdominal myomectomy, with the use of Foley catheters as improvise equipment for tourniquet and abdominal drain. Anti-adhesion agent was not used. Case 2 was a 47-year-old nulliparous Nigerian teacher with giant fibroids (13.2 kg) who also initially had delayed surgery due to fear that fibroid surgery is a major operation that it may get complicated and she may die. Also, she was afraid that she may not have her womb in her next world if she gets reincarnated. She had total abdominal hysterectomy and bilateral salpingo-oophorectomy without complications. For both cases, pre-surgery leiomyosarcoma assessment with computed tomography scan or magnetic resonance imaging and anti-adhesion agent were not used due to very unaffordable high costs. These reports of giant uterine fibroids (leiomyoma or myomas) are very rare gynecological entity, and management can be successful despite overwhelming challenges in low-income countries. Cheaper, affordable and available alternatives (improvises) can be resorted to for tackling its challenges in low-income settings.

Eight-hour versus 24-h urethral catheter removal following elective caesarean section for reducing significant bacteriuria: A randomized controlled trial.

BACKGROUND: There is no consensus on the preferred time to remove urethral catheter post caesarean section. AIM: To compare rate of significant bacteriuria and urinary retention following 8-h (study) and 24-h urethral catheter removal (control) post elective caesarean section. METHODS: A randomized controlled trial of eligible participants that underwent elective caesarean section under spinal anaesthesia between March 2019 and November 2019 was conducted. Participants (150 in each arm) were randomly assigned (1:1 ratio) to either 8-h or 24-h group. Primary outcome measures included rates of significant bacteriuria 48-h post-operatively and acute urine retention 6-h post urethral catheter removal. Analysis was by Intention-to-treat. (www.pactr.org:PACTR202105874744483). RESULTS: There were 150 participants randomized into each arm and data collection was complete. Significant bacteriuria was less in 8-h group (3% versus 6.0%; risk ratio (RR): 0.85 CI: 0.60 to 5.66; p = 0.274), though not significant. Acute urinary retention requiring repeat catheterisation was significantly higher in 8-h group (11(7.3%) versus 0(0.0%); RR: 0.07; CI: 0.87 to 0.97; p = 0.001). Mean time until first voiding was slightly higher in 8-h group (211.4 ± 14.3 min versus 190.0 ± 18.3 min; mean difference (MD): 21.36; CI: -24.36 to 67.08; p = 0.203); but patient in this group had a lower mean time until ambulation (770.0 ± 26.1 min versus 809 ± 26.2 min; MD: -38.8; CI: -111.6 to 34.0; p = 0.300). The 8-h group were significantly more satisfied (82/150 (54.7%) versus 54/150 (36.0%); p = 0.001). CONCLUSIONS: An 8-h group was associated with significant clinical satisfaction and acute urine retention compared to 24-h removal. The timing of urethral catheter removal did not affect rate of significant bacteriuria and other outcomes.

A randomized controlled clinical trial on peripartum effects of delayed versus immediate umbilical cord clamping on term newborns.

OBJECTIVES: To compare the hemoglobin and serum bilirubin concentration of term newborn following delayed and immediate umbilical cord clamping. METHODS: A randomized controlled trial of eligible parturients with singleton pregnancy delivered between July 1, 2019 and September 30, 2020 were randomly assigned (1:1 ratio) to either delayed clamping of umbilical cord (60 s after delivery) or immediate clamping (0-15 s) was done. The primary outcome measures included hemoglobin and bilirubin levels of the newborn measured at birth and 48 h of life. Intention-to-treat principle was applied to analysis (www.pactr.org: PACTR201906668876480). RESULTS: One hundred and two newborns were randomized into each group and none was lost to follow-up. Participants in both groups had similar socio-demographic and clinical characteristics. At 0 h of birth, cord blood hemoglobin concentration and total bilirubin values were not significantly different between the two groups (p > 0.05). At 48 h of birth, mean hemoglobin concentration was significantly higher in delayed clamping group than immediate clamping group (16.51 ± 1.71 g/dl vs 15.16 ± 2.27 g/dl; p < 0.001) but total mean bilirubin concentration was not significantly different (3.88 ± 1.54 mg/dl vs 3.71 ± 1.20 mg/dl; p = 0.380). There was no significant difference in postpartum hemorrhage (p = 0.653), neonatal jaundice (p = 0.856), and need for phototherapy (p = 0.561) while respiratory symptoms, polycythemia and anemia were not reported. CONCLUSION: Delayed cord clamping at childbirth is more advantageous for term infants in terms of more hemoglobin concentration compared to traditional immediate cord clamping. The maternal and perinatal complications were either not significantly different or absent.

Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy.

PURPOSE: To determine the benefits and safety of direct trocar insertion versus Veress needle technique in obese women undertaking diagnostic laparoscopy procedures. METHODS: Randomized-controlled trial on 135 obese women undergoing diagnostic laparoscopy and dye test for infertility was conducted. Women were randomly assigned to either direct trocar access (n = 68) or Veress needle access (n = 67) before achieving pneumoperitoneum. The same surgeon executed the laparoscopic techniques with a single-puncture technique. The primary outcome measures included total length of the procedure and incidence of any complications, while the mean laparoscopic entry time, volume of CO2 required, and total of tries needed to attain successful entry were secondary outcomes. Intention-to-treat principle was applied to analysis. RESULTS: Women in both groups had similar socio-demographic and clinical characteristics and none were lost to follow-up. The overall length of the procedure was significantly lesser in the direct trocar group compared to the Veress needle group (9.9 ± 6.0 vs 16.7 ± 4.7 min; p < 0.001). No significant differences occurred in other outcomes including mean entry time, volume of CO2 used, number of attempts for successful entry, and major/minor complications (p > 0.05). CONCLUSIONS: Direct trocar technique may be an effective alternative to Veress needle for pneumoperitoneum in obese women for diagnostic laparoscopy. It has a comparable rapid laparoscopic entry time but a significantly lower duration of the procedure and shorter exposure to anesthesia. Both methods are equally effective as there was no significant difference in the complications recorded. A greater sample trial may be essential for more corroborative substantiation. CLINICAL TRIAL REGISTRATION: PACTR201510000999192.

A double-blind placebo-controlled randomized trial on the effect of hyosine n-butyl bromide for improving duration of labor in term pregnancies.

AIM: To compare the effectiveness of intramuscular hyocine n-butyl bromide (HBB) with placebo for shortening the duration of the first stage of labor in term pregnancies. METHODS: A double blind placebo-controlled randomized trial of parturients who presented at term in the active phase of labor was conducted. They were randomly (1:1 ratio) given intramuscular injection of either 40 mg (2 mL) of HBB or 2 mL of water for injection as a placebo. The primary outcome measures were the duration of first and second stages of labor. Subgroup analysis of primigravid and multigravid women were also performed for various outcomes. We did intention-to-treat analysis. RESULTS: Sixty-two women were randomized to each group and none were lost to follow-up. Baseline characteristics were similar between the HBB and placebo groups. The mean duration of first stage of labor was noted to be significantly shorter in the HBB group for both the primigravidas (246.6 ± 21.9 vs 391.8 ± 56.6 min for control; P < 0.001) and for multigravidas (205.9 ± 17.8 vs 323.8 ± 16.0 min for control;P < 0.001).There was also significantly shorter duration of second stage of labor in the HBB group (primigravida: P = 0.013; multigravida: P = 0.016). The duration of third stage of labor, mode of delivery and maternal and/or neonatal outcomes for both classes of parturients were not significantly different. CONCLUSION: HBB is effective in reducing the first and second stages of labor without adverse maternal or neonatal outcome. HBB does not significantly influence the duration of third stage of labor including mode of delivery. More evidence is needed to further explore the potential useful role of HBB in the active phase of labor.