Hypertensive disorders of pregnancy among women with cardiovascular disease in Norway: A historical cohort study.

INTRODUCTION: Women with cardiovascular disease may be at increased risk of hypertensive disorders of pregnancy (HDP). We aimed to: (1) Investigate the occurrence of HDP in a cohort of pregnant women with cardiovascular disease and compare it with the occurrence in the general population. (2) Assess the association between maternal cardiovascular risk and risk of HDP. MATERIAL AND METHODS: We reviewed clinical data on a cohort of 901 pregnancies among 708 women with cardiovascular disease who were followed at the National Unit for Pregnancy and Heart Disease and gave birth at Oslo University Hospital between 2003 and 2018. The exposure under study was maternal cardiovascular risk, classified as low, moderate, or high based on a modified classification by the World Health Organization. The main outcome of interest was HDP, which included pre-eclampsia and gestational hypertension. The proportion of HDP cases in the general population in the same period was extracted from the Medical Birth Registry of Norway. We used logistic regression to estimate crude and adjusted odds ratios (OR) of HDP, with associated 95% confidence intervals (CIs), for women with moderate- and high cardiovascular risk compared to women with low risk. RESULTS: The occurrence of HDP in the study cohort was 12.1% (95% CI: 10.0%-14.4%) and varied between 8.7% (95% CI: 6.5%-11.3%) in the low-risk group, 15.7% (95% CI: 11.1%-21.4%) in the moderate-risk group, and 22.2% (95% CI: 15.1%-30.8%) in the high-risk group. By contrast, the nationwide occurrence of HDP was 5.1% (95% CI: 5.1%-5.2%). In the study cohort, the proportions of pregnancies with gestational hypertension and pre-eclampsia were similar (6.3% and 5.8%, respectively). Compared to pregnancies with low cardiovascular risk, the adjusted OR of HDP was 2.04 (95% CI: 1.21-3.44) in the moderate-risk group and 2.99 (95% CI: 1.73-5.18) in the high-risk group. CONCLUSIONS: The occurrence of hypertensive disease of pregnancy in the study cohort was more than doubled compared to the general population in Norway. The risk of HDP increased with maternal cardiovascular risk group. We recommend taking into account maternal cardiovascular risk group when assessing risk and prophylaxis of HDP.

The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial.

BACKGROUND: Prolonged labor is a common condition associated with maternal and perinatal complications. The standard treatment with oxytocin for augmentation of labor increases the risk of adverse outcomes. Hyoscine butylbromide is a spasmolytic drug with few side effects shown to shorten labor when used in a general population of laboring women. However, research on its effect on preventing prolonged labor is lacking. We aimed to assess the effect of hyoscine butylbromide on the duration of labor in nulliparous women showing early signs of slow labor. METHODS AND FINDINGS: In this double-blind randomized placebo-controlled trial, we included 249 nulliparous women at term with 1 fetus in cephalic presentation and spontaneous start of labor, showing early signs of prolonged labor by crossing the alert line of the World Health Organization (WHO) partograph. The trial was conducted at Oslo University Hospital in Norway from May 2019 to December 2021. One hundred and twenty-five participants were randomized to receive 1 ml hyoscine butylbromide (Buscopan) (20 mg/ml), while 124 received 1 ml sodium chloride intravenously. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered sealed envelopes. The primary outcome was duration of labor from administration of the investigational medicinal product (IMP) to vaginal delivery, which was analyzed by Weibull regression to estimate the cause-specific hazard ratio (HR) of vaginal delivery between the 2 treatment groups, with associated 95% confidence interval (CI). A wide range of secondary maternal and perinatal outcomes were also evaluated. Time-to-event outcomes were analyzed by Weibull regression, whereas continuous and dichotomous outcomes were analyzed by median regression and logistic regression, respectively. All main analyses were based on the modified intention-to-treat (ITT) set of eligible women with signed informed consent receiving either of the 2 treatments. The follow-up period lasted during the postpartum hospital stay. All personnel, participants, and researchers were blinded to the treatment allocation. Median (mean) labor duration from IMP administration to vaginal delivery was 401 (440.8) min in the hyoscine butylbromide group versus 432.5 (453.6) min in the placebo group. We found no statistically significant association between IMP and duration of labor from IMP administration to vaginal delivery: cause-specific HR of 1.00 (95% CI [0.77, 1.29]; p = 0.993). Among 255 randomized women having received 1 dose of IMP, 169 women (66.3%) reported a mild adverse event: 75.2% in the hyoscine butylbromide group and 57.1% in the placebo group (Pearson's chi-square test: p = 0.002). More than half of eligible women were not included in the study because they did not wish to participate or were not included upon admission. The participants might have represented a selected group of women reducing the external validity of the study. CONCLUSIONS: One intravenous dose of 20 mg hyoscine butylbromide was not found to be superior to placebo in preventing slow labor progress in a population of first-time mothers at risk of prolonged labor. Further research is warranted to answer whether increased and/or repeated doses of hyoscine butylbromide might have an effect on duration of labor. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03961165) EudraCT (2018-002338-19).

Outpatient labor induction-Exploring future potential by assessing eligibility in a historical cohort.

INTRODUCTION: Labor induction rates have increased over the last decades, and in many high-income countries, more than one in four labors are induced. Outpatient management of labor induction has been suggested in low-risk pregnancies to improve women's birth experiences while also promoting a more efficient use of healthcare resources. The primary aim of this paper was to assess the proportion of women in a historical cohort that would have been eligible for outpatient labor induction with oral misoprostol. Second, we wanted to report safety outcomes and assess efficacy outcomes for mothers and infants in pregnancies that met the criteria for outpatient care. MATERIAL AND METHODS: Criteria for outpatient labor induction with oral misoprostol were applied to a historical cohort of women with induction of labor at two Norwegian tertiary hospitals in the period January 1, through July 31, 2021. The criteria included low-risk women with an unscarred uterus expecting a healthy, singleton baby in cephalic position at term. The primary outcome was the proportion of women eligible for outpatient labor induction. Secondary outcomes included reasons for ineligibility and, for eligible women, safety and efficacy outcomes. RESULTS: Overall, 29.7% of the 1320 women who underwent labor induction in a singleton term pregnancy met the criteria for outpatient labor induction. We identified two serious adverse events that potentially could have occurred outside the hospital if the women had received outpatient care. The mean duration from initiation of labor induction to administration of the last misoprostol was 22.4 h. One in 14 multiparous women gave birth within 3 h after the last misoprostol dose. CONCLUSIONS: In this historical cohort, three in ten women met the criteria for outpatient management of labor induction with oral misoprostol. Serious adverse events were rare. The average time span from the initiation of labor induction to the last misoprostol was nearly 24 h. This suggests a potential for low-risk women with an induced labor to spend a substantial period of time at home before labor onset. However, larger studies testing or evaluating labor induction with oral misoprostol as an outpatient procedure are needed to draw conclusions.

High prevalence of pre-eclampsia in women with coarctation of the aorta.

Aims: The aim was to study pregnancy outcomes in women with coarctation of the aorta (CoA) and associations to hypertensive disorders of pregnancy. Maternal morbidity and mortality are higher in women with heart disease and pre-eclampsia. Chronic hypertension, frequently encountered in CoA, is a risk factor for pre-eclampsia. Methods and results: Clinical data from the National Unit for Pregnancy and Heart Disease database was reviewed for pregnant women with CoA from 2008 to 2021. The primary outcome was hypertensive pregnancy disorders. The secondary outcomes were other cardiovascular, obstetric, and foetal complications. Seventy-six patients were included, with a total of 87 pregnancies. Seventeen (20%) patients were treated for chronic hypertension before pregnancy. Fifteen (20%) patients developed pre-eclampsia, and 5 (7%) had pregnancy-induced hypertension. Major adverse cardiac events developed in four (5%) patients, with no maternal or foetal mortality. Maternal age at first pregnancy [odds ratio (OR) 1.37], body mass index before first pregnancy (OR 1.77), and using acetylsalicylic acid from the first trimester (OR 0.22) were statistically significantly associated with pre-eclampsia. At follow-up (median) 8 years after pregnancy, 29 (38%) patients had anti-hypertensive treatment, an increase of 16% compared to pre-pregnancy. Five (7%) patients had progression of aorta ascendens dilatation to >40 mm, seven (9%) had an upper to lower systolic blood pressure gradient >20 mmHg, and six (8%) had received CoA re-intervention. Conclusion: Pre-eclampsia occurred in 20% of women with CoA in their first pregnancy. All pre-eclamptic patients received adequate anti-hypertensive treatment. All CoA patients were provided multi-disciplinary management, including cardiologic follow-up, to optimize maternal-foetal outcomes.

Use of emergency primary care among pregnant undocumented migrants over ten years: an observational study from Oslo, Norway.

OBJECTIVE: To compare consultations with pregnant undocumented migrants at emergency primary health care to consultations with pregnant residents of Norway. DESIGN: A cross-sectional study of consultations at several time points. SETTING: The study was conducted at the Oslo Accident and Emergency Outpatient Clinic (OAEOC), the main emergency primary care service in Oslo, Norway. SUBJECTS: Consultations with pregnant patients without a Norwegian identity number seeking care at the Department of Emergency General Practice at the OAEOC were identified through a manual search of registration lists from 2009 to 2019. The consultations were categorized by women's residency status as 'probably documented migrant', 'uncertain migrant status', or 'probably undocumented migrant'. We also extracted aggregated data for women with a Norwegian identity number (i.e. residents) presenting in consultations with pregnancy-related (ICPC-2 chapter W) conditions. MAIN OUTCOME MEASURES: Manchester Triage System urgency level at presentation, and hospitalization. RESULTS: Among 829 consultations with female patients categorized as probably undocumented migrants, we found 27.1% (225/829) with pregnant women. About half of the pregnant women (54.6% (123/225)) presented with a pregnancy-related condition. Pregnant women that were probably undocumented migrants had an increased risk of being triaged with a high level of urgency at presentation (relative risk (RR) 1.86, 95% CI 1.14-3.04) and being hospitalized (RR 1.68, 95% CI 1.21-2.34), compared to pregnant residents. CONCLUSION: Pregnant undocumented migrants were more severely sick when presenting to emergency primary care services than pregnant residents. Increased access to primary care and emergency primary care services for pregnant undocumented migrants is urgently needed.

Restricted access to primary care may increase the use of primary care facilities intended for emergency care.A considerable proportion of the consultations with undocumented migrant women at the emergency primary care services are related to pregnancy.Consultations with pregnant undocumented migrants more often contained severe pregnancy-related conditions compared to consultations with pregnant residents of Norway.Interventions to increase access to primary care for pregnant undocumented migrants are urgently needed.

Intrapartum pudendal nerve block analgesia and childbirth experience in primiparous women with vaginal birth: A cohort study.

BACKGROUND: A negative childbirth experience has short- and long-term consequences for both mother and child. This study aimed to investigate the association between intrapartum pudendal nerve block (PNB) analgesia and childbirth experience. METHODS: Primiparous women with a singleton cephalic vaginal live births at term at Oslo University Hospital from January 1, 2017, to June 1, 2019, were eligible for inclusion. The main outcome was total score on a childbirth experience questionnaire (range 1.0-4.0, higher score indicates better childbirth experience). An absolute risk difference of 0.10 was considered clinically relevant. Propensity score matching was used to adjust for differences in baseline characteristics between women with and without PNB. The analyses were stratified by spontaneous vs instrumental birth. Subanalyses of the questionnaire's domains (own capacity, professional support, perceived safety, and participation) were performed. RESULTS: Of 979 participating women, mean age was 32 years. Childbirth experience did not differ between women with and without PNB, either in spontaneous (absolute risk difference of the mean: -0.05, P value 0.36) or in instrumental birth (absolute risk difference of the mean: 0.03, P value 0.61). There were no statistically significant differences between PNB group scores for the separate domains. CONCLUSIONS: Women's childbirth experiences did not differ between birthing people with or without PNB, either in spontaneous or in instrumental births. The clinical implications of our study should be interpreted in light of the pain-relieving effects of PNB.PNB should be provided on clinical indication, including for individuals with severe labor pain.

Caesarean sections among immigrant women with different levels of education. / Keisersnitt blant utenlandsfødte kvinner med ulike utdanningsnivåer.

BACKGROUND: Studies have shown a high incidence of emergency caesarean sections among immigrant women, especially those born in Sub-Saharan Africa, but the risk of planned and emergency caesarean section varies with the mother's level of education. The proportion of women with little or no education is higher among those born in Sub-Saharan Africa and other low- and middle-income countries than those born in Norway. We therefore wanted to investigate the relationship between maternal birthplace, level of education and risk of caesarean section. MATERIAL AND METHOD: The study was based on all births recorded in the Medical Birth Registry of Norway between 2008 and 2017 linked to data from Statistics Norway. Maternal birthplace, divided into four categories, was the exposure variable. The outcome was planned or emergency caesarean section. We used multinomial logistic regression and stratified the analyses by level of education. Norwegian-born women constituted the reference group. RESULTS: Of 572 349 births, immigrant women accounted for 26.6 %. Caesarean sections and emergency caesareans made up 15.1 % and 9.6 % of all births respectively. Norwegian-born women had the highest proportion of planned caesarean sections (5.7 %), while women born in Sub-Saharan Africa had the highest proportion of emergency caesareans (16.3 %). Among women with a higher education, the proportion of emergency caesareans was 8.3 % among Norwegian-born women and 18.1 % among women born in Sub-Saharan Africa (adjusted relative risk 2.41, 95 % confidence interval 2.18 to 2.66). INTERPRETATION: The impact of education level on risk of caesarean section differed between immigrant women and Norwegian-born women.

Study protocol for the BUSCopan in LABor (BUSCLAB) study: A randomized placebo-controlled trial investigating the effect of butylscopolamine bromide to prevent prolonged labor.

BACKGROUND: First-time mothers are prone to prolonged labor, defined as the crossing of partograph alert or action lines. Prolonged labor may occur among as many as one out of five women, and is associated with a range of adverse birth outcomes. Oxytocin is the standard treatment for prolonged labor, but has a narrow therapeutic window, several adverse effects and limited efficacy. Despite poor evidence, labor wards often use antispasmodic agents to treat prolonged labor. The antispasmodic drug butylscopolamine bromide (Buscopan®) may shorten duration of labor, but studies on prevention of prolonged labor are lacking. In this randomized double-blind placebo-controlled clinical trial, we aim to evaluate the effect of butylscopolamine bromide on duration of labor in first-time mothers showing first signs of slow labor progress by crossing the World Health Organization partograph alert line. METHODS AND ANALYSIS: The study is a single center study at Oslo University Hospital, Oslo, Norway. We will recruit 250 primiparous women with spontaneous labor start at term. Women are included in the first stage of labor if they show signs of slow labor progress, defined as the crossing of the partograph alert line with a cervical dilation between 3-9 cm. Participants are randomized 1:1 to either 20 mg intravenous butylscopolamine bromide or intravenous placebo (1 mL sodium chlorine 9 mg/mL). We considered a mean difference of 60 minutes in labor duration clinically relevant. The primary outcome is duration of labor from the provision of the investigational medicinal product to vaginal delivery. The secondary outcomes include change in labor pain, use of oxytocin augmentation, delivery mode, and maternal birth experience. The primary data for the statistical analysis will be the full analysis set and will occur on completion of the study as per the prespecified statistical analysis plan. The primary outcome will be analyzed using Weibull regression, and we will treat cesarean delivery as a censoring event.

Use of non-governmental maternity services and pregnancy outcomes among undocumented women: a cohort study from Norway.

BACKGROUND: In 2011 Norway granted undocumented women the right to antenatal care and to give birth at a hospital but did not include them in the general practitioner and reimbursement schemes. As a response to limited access to health care, Non-Governmental Organizations (NGO) have been running health clinics for undocumented migrants in Norway's two largest cities. To further facilitate universal health coverage, there is a need to investigate how pregnant undocumented women use NGO clinics and how this affects their maternal health. We therefore investigated the care received, occurrence of pregnancy-related complications and pregnancy outcomes in women receiving antenatal care at these clinics. METHODS: In this historic cohort study we included pregnant women aged 18-49 attending urban NGO clinics from 2009 to 2020 and retrieved their medical records from referral hospitals. We compared women based on region of origin using log-binominal regression to estimate relative risk of adverse pregnancy outcomes. RESULTS: We identified 582 pregnancies in 500 women during the study period. About half (46.5%) the women sought antenatal care after gestational week 12, and 25.7% after week 22. The women had median 1 (IQR 1-3) antenatal visit at the NGO clinics, which referred 77.7% of the women to public health care. A total of 28.4% of women were referred for induced abortion. In 205 retrieved deliveries in medical records, there was a 45.9% risk for any adverse pregnancy outcome. The risk of stillbirth was 1.0%, preterm birth 10.3%, and emergency caesarean section 19.3%. CONCLUSION: Pregnant undocumented women who use NGO clinics receive substandard antenatal care and have a high risk of adverse pregnancy outcomes despite low occurrence of comorbidities. To achieve universal health coverage, increased attention should be given to the structural vulnerabilities of undocumented women and to ensure that adequate antenatal care is accessible for them.

Maternal beta-blocker dose and risk of small-for gestational-age in women with heart disease.

INTRODUCTION: Beta-blockers are prescribed for many pregnant women with heart disease, but whether there is a dose-dependent effect on fetal growth remains to be examined. We aimed to investigate if antenatal beta-blocker use and dose were associated with delivering a small-for-gestational-age infant among women with heart disease. MATERIAL AND METHODS: Our cohort included women with heart disease who delivered at Oslo University Hospital between 2006 and 2015. Maternal heart disease was classified into modified WHO risk scores. Women with beta-blocker treatment were dichotomized into whether they had been treated with a low or high dose based on clinical factors. We compared the risk of delivering a small-for-gestational-age infant in women exposed to high doses, low doses, or with no exposure to antenatal beta-blockers while adjusting for severity of maternal heart disease in logistic regression models. RESULTS: Of a total of 540 pregnancies among women with heart disease, 163 (30.2%) were exposed to beta-blocker treatment. The majority were treated with metoprolol (86.5%). Almost twice as many babies in the beta-blocker group were small-for-gestational-age, compared with the non-exposed group (19.8 vs 9.5%, P < 0.001). Women using a high-dose beta-blocker had a five-fold increased risk of delivering a small-for-gestational-age infant compared with non-exposure (adjusted odds ratio [aOR] 4.89, 95% confidence interval [CI] 2.22-10.78, P < 0.001). Women using a low dose of beta-blocker had a two-fold increased risk of delivering a small-for-gestational-age infant; however, the confidence interval included the null (aOR 1.75, 95% CI 0.83-3.72, P = 0.143). Results when restricting the analyses to metoprolol showed the same pattern, but with attenuation of risks. CONCLUSIONS: We found a five-fold increased risk of delivering a small-for-gestational-age infant in women with heart disease treated with a high dose of beta-blocker, and a two-fold increased risk among those treated with a low dose, showing an apparent dose-response relation. Close monitoring of fetal growth is warranted among women with heart disease treated with beta-blockers. As drug therapy in pregnancy concerns both mother and fetus, an optimum balance for both should be the goal.

Female genital cutting in women living in Norway - consequences and treatment. / Omskjæring hos kvinner bosatt i Norge ­ konsekvenser og behandling.

BACKGROUND: Seven Norwegian hospitals offer an outpatient service for women who have undergone female genital cutting (FGC). This study presents symptoms, findings and treatment in women who were examined at the outpatient clinics in the period 2004-2015. MATERIAL AND METHOD: Each hospital identified patients by searching for relevant diagnostic and procedure codes. All those who had been examined at the outpatient clinics were included. Data were retrieved from patient records. RESULTS: A total of 913 women were included. The median age at the time of undergoing FGC was seven years, and at the time of consultation, 26 years. Almost half of the women were pregnant. The majority (81 %) had FGC type III (infibulation). Of these, 87 % had gynaecological problems. Of women with types I and II FGC, 55 % and 70 %, respectively, reported gynaecological problems. Altogether 64 % received surgical treatment, primarily deinfibulation (98 %). Few complications were recorded. INTERPRETATION: In many young, non-pregnant infibulated women, FGC-related problems that can be treated with deinfibulation may have been present since childhood and adolescence. There is probably an unmet need for treatment, irrespective of the type of FGM.

Association between Maternal Origin, Pre-Pregnancy Body Mass Index and Caesarean Section: A Nation-Wide Registry Study.

AIMS: To explore the association between maternal origin and birthplace, and caesarean section (CS) by pre-pregnancy body mass index (BMI) and length of residence. METHODS: We linked records from 118,459 primiparous women in the Medical Birth Registry of Norway between 2013 and 2017 with data from the National Population Register. We categorized pre-pregnancy BMI (kg/m2) into underweight (<18.5), normal weight (18.5-24.9) and overweight/obese (≥25). Multinomial regression analysis estimated crude and adjusted relative risk ratios (RRR) with 95% confidence intervals (CI) for emergency and elective CS. RESULTS: Compared to normal weight women from Norway, women from Sub-Saharan Africa and Southeast Asia/Pacific had a decreased risk of elective CS (aRRR = 0.57, 95% CI 0.37-0.87 and aRRR = 0.56, 0.41-0.77, respectively). Overweight/obese women from Europe/Central Asia had the highest risk of elective CS (aRRR = 1.42, 1.09-1.86). Both normal weight and overweight/obese Sub-Saharan African women had the highest risks of emergency CS (aRRR = 2.61, 2.28-2.99; 2.18, 1.81-2.63, respectively). Compared to women from high-income countries, the risk of elective CS was increasing with a longer length of residence among European/Central Asian women. Newly arrived migrants from Sub-Saharan Africa had the highest risk of emergency CS. CONCLUSION: Women from Sub-Saharan Africa had more than two times the risk of emergency CS compared to women originating from Norway, regardless of pre-pregnancy BMI.

Intrapartum pudendal nerve block analgesia and risk of postpartum urinary retention: a cohort study.

INTRODUCTION AND HYPOTHESIS: Pudendal nerve block analgesia (PNB) is used as pain relief in the final stage of childbirth. We hypothesized that PNB is associated with higher rates of postpartum urinary retention. METHODS: We performed a cohort study among primiparous women with a singleton, cephalic vaginal birth at Oslo University Hospital, Norway. Women receiving PNB were included in the exposed group, while the subsequent woman giving birth without PNB was included in the unexposed group. We compared the likelihood of postpartum urinary retention, defined as catheterization within 3 h after birth. Logistic regression analysis stratified by mode of delivery was performed adjusting for epidural analgesia, episiotomy and birth unit. RESULTS: Of the 1007 included women, 499 were exposed to PNB and 508 were unexposed. In adjusted analyses, women exposed to PNB did not differ in likelihood of postpartum urinary retention compared to women unexposed to PNB in either spontaneous (odds ratio[OR]: 0.82, 95% confidence interval [CI] 0.55-1.22) or instrumental (OR 1.45, 95% CI 0.89-2.39) births. Furthermore, no differences between the groups were observed with excessive residual urine volume or catheterization after > 3 h. CONCLUSIONS: PNB was associated with neither risk of postpartum urinary retention nor excessive residual urine volume and is therefore unlikely to hamper future bladder function.

The provision of epidural analgesia during labor according to maternal birthplace: a Norwegian register study.

BACKGROUND: The provision of epidural analgesia during labor is ideally a shared decision between the woman and her health care provider. However, immigrant characteristics such as maternal birthplace could affect decision-making and thus access to pain relief. We aimed to assess disparities in the provision of epidural analgesia in planned vaginal birth according to maternal region of birth. METHODS: We performed a nation-wide register study of 842,496 live-born singleton deliveries in Norway between 2000 and 2015. Maternal birthplace was categorized according to the Global Burden of Disease framework. The provision of epidural analgesia was compared in regression models stratified by parity and mode of delivery. RESULTS: Compared to native-born women, primiparous women from Latin America/Caribbean countries with an instrumental vaginal delivery were most likely to be provided epidural analgesia (OR 2.12, 95%CI 1.69-2.66), whilst multiparous women from Sub-Saharan Africa with a spontaneous vaginal delivery were least likely to be provided epidural analgesia (OR 0.42, 95% C 0.39-0.44). Longer residence time was associated with a higher likelihood of being provided analgesia, whereas effects of maternal education varied by Global Burden of Disease group. CONCLUSIONS: Disparities in the likelihood of being provided epidural analgesia were observed by maternal birthplace. Further studies are needed to consider whether the identified disparities represent women's own preferences or if they are the result of heterogeneous access to analgesia during labor.

A comparison of misoprostol vaginal insert and misoprostol vaginal tablets for induction of labor in nulliparous women: a retrospective cohort study.

BACKGROUND: Since Misoprostol Vaginal Insert (MVI - Misodel ®) was approved for labor induction in Europe in 2013, to date, no study has been published comparing MVI to Misoprostol vaginal tablets (MVT). The aim of this study, performed as part of a quality improvement project, was to compare the efficacy and safety of 200 µg MVI versus 25 µg MVT for labor induction in nulliparous women. METHODS: This retrospective cohort study included 171 nulliparous singleton term deliveries induced with MVI (n = 85) versus MVT (n = 86) at Oslo University Hospital Rikshospitalet, Norway, from November 2014 to December 2015. Primary outcomes were time from drug administration to delivery in hours and minutes and the rate of cesarean section (CS). Results were adjusted for Bishop Score and pre-induction with balloon catheter. RESULTS: Median time from drug administration to delivery was shorter in the MVI group compared to the MVT group (15 h 43 min versus 19 h 37 min, p = 0.011). Adjusted for confounding factors, mean difference was 6 h 3 min (p = 0.002). The risk of CS was 67% lower in the MVI group compared to the MVT group (11.8% versus 23.3%, OR = 0.33; adjusted 95% CI 0.13-0.81). Adverse neonatal outcomes did not differ between the groups. CONCLUSIONS: In a setting of routine obstetric care, MVI seems to be a more efficient labor induction agent than MVT, and with a lower CS rate and no increase in adverse infant outcomes.

Reasons for and Experiences With Surgical Interventions for Female Genital Mutilation/Cutting (FGM/C): A Systematic Review.

BACKGROUND: Because female genital mutilation/cutting (FGM/C) leads to changes in normal genital anatomy and functionality, women are increasingly seeking surgical interventions for their FGM/C-related concerns. AIM: To conduct a systematic review of empirical quantitative and qualitative research on interventions for women with FGM/C-related complications. METHODS: We conducted systematic searches up to May 2016 in 16 databases to obtain references from different disciplines. We accepted all study designs consisting of girls and women who had been subjected to FGM/C and that examined a reparative intervention for a FGM/C-related concern. We screened the titles, abstracts, and full texts of retrieved records for relevance. Then, we assessed the methodologic quality of the included studies and extracted and synthesized the study data. OUTCOMES: All outcomes were included. RESULTS: Of 3,726 retrieved references, 71 studies including 7,291 women were eligible for inclusion. We identified three different types of surgical intervention: defibulation or surgical separation of fused labia, excision of a cyst with or without some form of reconstruction, and clitoral or clitoral-labial reconstruction. Reasons for seeking surgical interventions consisted of functional complaints, sexual aspirations, esthetic aspirations, and identity recovery. The most common reasons for defibulation were a desire for improved sexual pleasure, vaginal appearance, and functioning. For cyst excision, cystic swelling was the main reason for seeking excision; for reconstruction, the main reason was to recover identity. Data on women's experiences with a surgical intervention are sparse, but we found that women reported easier births after defibulation. Our findings also suggested that most women were satisfied with defibulation (overall satisfaction = 50-100%), typically because of improvements in their sexual lives. Conversely, the results suggested that defibulation had low social acceptance and that the procedure created distress in some women who disliked the new appearance of their genitalia. Most women were satisfied with clitoral reconstruction, but approximately one third were dissatisfied with or perceived a worsening in the esthetic look. CLINICAL TRANSLATION: The information health care professionals give to women who seek surgical interventions for FGM/C should detail the intervention options available and what women can realistically expect from such interventions. STRENGTHS AND LIMITATIONS: The systematic review was conducted in accordance with guidelines, but there is a slight possibility that studies were missed. CONCLUSION: There are some data on women's motivations for surgery for FGM/C-related concerns, but little is known about whether women are satisfied with the surgery, and experiences appear mixed. Berg RC, Taraldsen S, Said MA, et al. Reasons for and Experiences With Surgical Interventions for Female Genital Mutilation/Cutting (FGM/C): A Systematic Review. J Sex Med 2017;14:977-990.