Yadav Garima, Gupta Shivani, Singh Pratibha, Kansara Megha, Kathuria Priyanka, Gothwal Meenakshi, Sharma Charu
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India.
J Family Med Prim Care. 2022 Nov;11(11):7042-7047. doi: 10.4103/jfmpc.jfmpc_884_22. Epub 2022 Dec 16.
Pre-term birth (PTB) is the leading cause of mortality and morbidity in newborn and infants. One of the proposed theories is the withdrawal of progesterone, either actual or functional, to be an antecedent to the onset of labor. The aim of the study is to evaluate the role of vaginal progesterone in delaying delivery following an episode of arrested pre-term labor.
This is a pragmatic open-label randomized controlled trial that was conducted in the Department of Obstetrics and Gynecology at All India Institute of Medical Sciences, Jodhpur. Hundred patients with singleton pregnancies presenting with pre-term labor between 24 and 34 weeks of gestation and treated successfully with acute tocolysis for 48 hours and steroids covered were randomized to receive either progesterone 400 mg vaginal suppository or no treatment.
The primary outcome was the duration of randomization to delivery interval, which was significantly higher in the study than in the control group (28 days versus 10 days). The secondary outcomes such as gestational age at delivery was also higher in the study group compared to the control group (82% versus 60% delivered after 37 weeks in the study group and control group, respectively). The neo-natal outcomes such as birth weight (2802 grams versus 2324 grams), incidence of respiratory distress syndrome (RDS) (13% versus 26%), and newborn intensive care unit (NICU) admission (17% versus 31%) were lower in the study group, which signifies decreased neo-natal morbidities and mortalities in pre-term labor treated with maintenance tocolysis in the form of vaginal progesterone.
Administration of vaginal progesterone (400 mg, daily) following an episode of arrested pre-term labor significantly increased the duration to delivery interval; that is, it reduced the rate of PTB before 37, 32, and 28 weeks of gestation among women. It further reduced the neo-natal morbidities such as RDS and NICU admission and increased the birth weight among infants of women assigned to progesterone treatment.
早产是新生儿和婴儿死亡及发病的主要原因。一种提出的理论是，孕酮的实际或功能性撤退是分娩开始的先兆。本研究的目的是评估阴道用孕酮在延迟早产宫缩停止后的分娩中的作用。
这是一项实用的开放标签随机对照试验，在焦特布尔全印度医学科学研究所妇产科进行。100例单胎妊娠、妊娠24至34周出现早产且成功接受急性宫缩抑制治疗48小时并使用了类固醇的患者被随机分为两组，一组接受400mg阴道孕酮栓剂治疗，另一组不接受治疗。
主要结局是随机分组至分娩间隔的持续时间，研究组显著长于对照组（28天对10天）。次要结局如分娩时的孕周，研究组也高于对照组（研究组和对照组分别有82%和60%在37周后分娩）。研究组的新生儿结局如出生体重（2802克对2324克）、呼吸窘迫综合征（RDS）发生率（13%对26%）和新生儿重症监护病房（NICU）入住率（17%对31%）较低，这表明以阴道孕酮形式进行维持宫缩抑制治疗的早产患者新生儿发病率和死亡率降低。
早产宫缩停止后给予阴道孕酮（每日400mg）显著延长了至分娩间隔的时间；也就是说，降低了女性在妊娠37、32和28周前早产的发生率。它还进一步降低了RDS和NICU入住等新生儿发病率，并增加了接受孕酮治疗女性婴儿的出生体重。
