Effect of nifedipine administration before embryo transfer on reproductive outcome in ICSI cycles, a double-blind control trial study.

PURPOSE: Nifedipine is a calcium channel blocker with smooth muscle relaxing properties. This study set out to investigate the efficacy of nifedipine administered orally before embryo transfer (ET) on the improvement of the intracytoplasmic sperm injection (ICSI) outcome. This randomized, double-blind, comparator-controlled, was carried out between 2019 and 2020 in the infertility center of Babol, Iran. 200 women candidates for ICSI and recipients of frozen-thawed ET aged 18-40 years were randomly assigned in the ratio 1:1 to an intervention group that received nifedipine 20 mg tablets orally 30 min before ET (n = 100) or to a group of placebo (n = 100). A randomization center in Babol University of Medical Science used computer-generated numbers to allocate treatments. The allocation treatment was blind to the participants, the sonographer of endometer monitoring, the staff of the ICSI laboratory, and the outcome assessor. The primary analysis was based on the intention-to-treat principle done on 200 participants, (n = 100), comparing chemical pregnancy rates in the two comparing groups at 14 days' follow-up after ET. Implantation rate and clinical pregnancy were considered secondary outcomes. RESULT: 200 participants were analyzed. There is no significant difference in the number of oocytes and the quality of embryos in the nifedipine and placebo groups. Despite a numerical increase in the rate of chemical pregnancy, there were no statistical differences in the study group versus the comparison group (24% vs 14%, P = 0.1, rate ratio 0.88, 95% CI 0.77 to 1.01), respectively. Also, no significant increase in clinical pregnancy was found compared with the placebo (17% vs 8%, P = 0.26, rate ratio 0.90, 0.81 to 1.00). CONCLUSION: Nifedipine administered orally 30 min before embryo transfer did not improve the chemical pregnancy rate, and clinical pregnancy rate in infertile women undergoing ICSI. This trial has been registered on the Iranian Clinical Trials Registration Site (IRCT) with the number IRCT20180417039338N3.

Psychological distress in pregnancy and postpartum: a cross-sectional study of Babol pregnancy mental health registry.

BACKGROUND: Psychological distress (PD) is a significant issue during pregnancy and postpartum, adversely affecting both children and mothers. This study aims to determine PD's prevalence and risk factors in a large Iranian population sample during pregnancy and postpartum. METHODS: A cross-sectional study was conducted using data from the Babol Pregnancy Mental Health Registry (located in the north of Iran) between June 2020 and March 2021. A total of 2305 women were included, with 1639 during pregnancy and 666 during postpartum. Psychological distress was assessed using the Brief Symptoms Inventory (BSI-18), and data were analyzed using independent t-tests and multiple logistic regressions. RESULTS: The prevalence of psychological distress, defined by a cut-off score of BSI ≥ 13, was 19% during pregnancy and 15% during postpartum. Multivariate logistic analysis revealed that high-risk pregnancy was the leading risk factor for psychological distress during the antenatal period (ß = 1.776, P < 0.001), as well as its three subscales: somatization (ß = 1.355, P = 0.019), anxiety symptoms (ß = 2.249, P < 0.001), and depressive symptoms (ß = 1.381, P = 0.028). Additionally, women with a gestational age < 20 weeks had a higher risk of psychological distress (ß = 1.344, P = 0.038) and the somatization subscale (ß = 1.641, P < 0.001). During the postpartum period, women residing in urban areas were at higher risk of psychological distress (ß = 1.949, P = 0.012), as well as two subscales: anxiety symptoms (ß = 1.998, P = 0.012) and depressive symptoms (ß = 1.949, P = 0.020). CONCLUSION: The high prevalence of psychological distress emphasizes detecting and treating PD during pregnancy and postpartum, particularly in women with high-risk pregnancies. This study suggests that obstetricians and midwives should implement programs to identify women experiencing psychological distress during early pregnancy through postpartum visits.