Nifedipine alone or combined with sildenafil citrate for management of threatened preterm labour: a randomised trial.

OBJECTIVE: To study the tocolytic action of nifedipine combined with sildenafil citrate (SC) and if the combination is superior to nifedipine alone in inhibiting threatened preterm labour (PTL). DESIGN: Prospective randomised study. SETTING: An Egyptian university hospital. POPULATION: Women with threatened PTL who received either nifedipine with SC or nifedipine alone. METHODS: Patients were randomly allocated to receive either (1) nifedipine 20 mg orally (stat dose), followed by 10 mg orally every 6-8 hours at the same time as vaginal administration of SC (25 mg at 8-hourly intervals) or (2) nifedipine alone. Medications were continued for 48-72 hours. MAIN OUTCOME MEASURES: The percentage of women who remained undelivered during hospitalisation. RESULTS: From January 2015 to November 2016, 239 women were randomised. The baseline characteristics of participants were similar. Nifedipine combined with SC was associated with more women remaining undelivered (81.8 versus 68.6%; P = 0.018) during hospitalisation. Regarding secondary outcomes, the addition of SC was also associated with fewer deliveries within 7 days of admission (9.1 versus 20.3%; P = 0.014), prolonged latency (29 versus 7 days; P = 0.002), fewer admissions to neonatal intensive care units (31.4 versus 44.1%; P = 0.043), fewer very preterm deliveries (from 28 to <32 weeks, 20.7 versus 38.1%; P = 0.043), and increased neonatal birthweight (1900 versus 1500 g; P = 0.018). CONCLUSIONS: Vaginal SC combined with nifedipine is an effective option for tocolytic therapy during threatened PTL. TWEETABLE ABSTRACT: Vaginal SC enhances the tocolytic effect of nifedipine.

Cervical mucus removal prior to intrauterine insemination: a randomized trial.

OBJECTIVE: To detect if removing the cervical mucus before performing intrauterine insemination (IUI) could improve pregnancy outcomes in patients with unexplained infertility. DESIGN: Prospective randomized study. SETTING: An Egyptian University Hospital. POPULATION: Seven hundred and fourteen couples with unexplained infertility who underwent intrauterine insemination (IUI) with or without cervical mucus removal. METHODS: Using computer-generated numbers, patients were randomly allocated to cervical-mucus-removal (removed from both internal and external os) or non-mucus-removal groups. Only participants were blinded as to group assignment. MAIN OUTCOME MEASURES: The clinical pregnancy rate. RESULTS: Of 714 IUI patients between November 2014 and March 2017, 361 were in the mucus removal group, and 353 in the non-mucus-removal group. Difficult catheterization was encountered in 17 cases out of 666 (2.6%) 12 in the cervical-mucus-removal group and five in the non-mucus-removal group). A total of 666 IUI cycles were completed while 48 were either cancelled or lost in their follow-up. The clinical pregnancy rate was significantly higher in the mucus-removal group [31.0% (n = 112)] than in the non-mucus-removal group [21.8% (n = 77); P = 0.005]. Ovarian hyperstimulation developed in 33 (4.6%) cases: 18 cervical mucus-removal and 15 non-mucus-removal. All except one were mild and managed with outpatient care. CONCLUSIONS: Cervical mucus removal before IUI could improve pregnancy outcomes in women with unexplained infertility. TWEETABLE ABSTRACT: Cervical mucus removal before IUI can improve pregnancy outcomes.

Early pregnancy screening for hypertensive disorders in women without a-priori high risk.

OBJECTIVES: To evaluate the performance of mean arterial pressure, uterine artery pulsatility index and soluble endoglin level alone or in combination in screening for hypertensive disorders in pregnant women without a-priori high risk. METHODS: This was a nested case-control study of women with singleton pregnancies without a-priori high risk who developed pregnancy-induced hypertensive complications. Women were enrolled into the study at 11-14 weeks' gestation, when mean arterial pressure and uterine artery pulsatility index were recorded and a blood sample was taken for measurement of soluble endoglin. Women were followed up in the clinic to detect development of any hypertensive disorder. Each affected case was matched with two normotensive control women with uncomplicated pregnancies that resulted in phenotypically normal infants. Mean values for each variable were compared between cases and controls. Sensitivities, positive predictive values and negative predictive values at fixed specificity were derived from receiver-operating characteristics (ROC) curves. RESULTS: During the study period, 2120 patients were examined. Of these, 170 (8.02%) were excluded because they were lost to follow-up and in 52 (2.45%) there was fetal death or miscarriage before 24 weeks' gestation. Thus, 1898 cases formed the cohort population. Of these, 89 (4.69%) patients developed complications (study group), including 16 (0.84%) cases with early pre-eclampsia (PE), 60 (3.16%) with late PE and 13 (0.68%) with gestational hypertension (GH). There were 49 (2.58%) cases of spontaneous preterm delivery before 34 weeks. The rest of the cohort population (1760 (92.73%) patients, the base cohort) were not affected by PE or GH. The control group comprised 178 patients. The best model for the prediction of any of the types of hypertensive disorders was one that combined mean arterial pressure with soluble endoglin (area under the ROC curve (AUC), 0.83). The predictive value of the three combined markers was highest for screening for early and late PE (AUC, 0.86 and 0.83, respectively). When each marker was considered alone, the highest prediction of any type of hypertensive disorder was achieved by mean arterial pressure (AUC, 0.73). Sensitivity was lowest for detection of GH when screening both by individual and by combined markers. CONCLUSION: First-trimester screening can be useful in predicting women at high risk of developing hypertensive disorders of pregnancy but more prospective longitudinal studies are needed.