Placental Related Diseases Research Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Rama IV Road, 10330, Pathumwan, Bangkok, Thailand.
BMC Pregnancy Childbirth. 2021 Jan 28;21(1):90. doi: 10.1186/s12884-021-03562-6.
Preterm birth is a major challenge in obstetric and perinatal care. It is the leading cause of neonatal death. The primary aim of this study was to evaluate the efficacy of oral dydrogesterone on latency period in managing preterm labor. The secondary aims were to evaluate the gestational age at delivery, percentage of preterm delivery before 34 weeks and 37 weeks, time to recurrent uterine contraction, pregnancy outcomes, neonatal outcomes, compliance and side effects.
This was a randomized, double blinded, placebo-controlled trial. Forty-eight pregnant women with preterm labor, singleton pregnancy, and gestational age of 24-34 weeks were enrolled into the study. The study group received 10 mg of oral dydrogesterone three times per day and the control group received placebo. All pregnant women received standard treatment with tocolytic and antenatal corticosteroids.
The median latency periods were not significantly different between the dydrogesterone group (27.5 days) and placebo group (34 days, p = 0.45). Additionally, there were no differences in the gestational age at delivery, percentage of preterm delivery before 34 weeks and 37 weeks, pregnancy outcomes, neonatal outcomes, compliance and side effects. However, the time to the recurrence of uterine contractions in participants that had recurrent preterm labor was longer in the dydrogesterone group than in the placebo group (30.6 ± 12.3 vs 13.7 ± 5.0 days, p = 0.01).
Adjunctive treatment with 30 mg of oral dydrogesterone could not prolong latency period in preterm labor when compared to placebo.
ClinicalTrials.gov (Clinical trials registration: NCT03935152 , registered on May 2,2019).
早产是产科和围产期护理的主要挑战。它是新生儿死亡的主要原因。本研究的主要目的是评估口服地屈孕酮对管理早产的潜伏期的疗效。次要目的是评估分娩时的胎龄、34 周前和 37 周前的早产百分比、复发子宫收缩的时间、妊娠结局、新生儿结局、依从性和副作用。
这是一项随机、双盲、安慰剂对照试验。将 48 名患有早产、单胎妊娠和 24-34 周妊娠的孕妇纳入研究。研究组每天口服 10 毫克地屈孕酮 3 次，对照组给予安慰剂。所有孕妇均接受标准的保胎治疗和产前皮质类固醇治疗。
地屈孕酮组（27.5 天）和安慰剂组（34 天，p = 0.45）的潜伏期中位数无显著差异。此外，两组的分娩时胎龄、34 周前和 37 周前的早产百分比、妊娠结局、新生儿结局、依从性和副作用均无差异。然而，在复发早产的参与者中，地屈孕酮组复发子宫收缩的时间长于安慰剂组（30.6 ± 12.3 天 vs 13.7 ± 5.0 天，p = 0.01）。
与安慰剂相比，30 毫克口服地屈孕酮辅助治疗不能延长早产的潜伏期。
ClinicalTrials.gov（临床试验注册：NCT03935152，注册于 2019 年 5 月 2 日）。
