Bed Rest After Preterm Premature Rupture of the Membranes
关键词
抽象
描述
Aims - To access the impact of bed rest in latency time to delivery, chorioamnionitis incidence and other maternal and neonatal outcomes in pregnancies complicated by PPROM, thus enabling proper sample size calculation for future powered RCT.
Study population and Sample size - Eligible patients included those with single pregnancies with PPROM at 24+0-33+6 weeks of gestation who were admitted to and delivering at our tertiary center. PPROM was diagnosed on the basis of patient's history and sterile speculum examination with visualization of amniotic fluid pooling in the vagina and/or leaking from the cervical canal. Exclusion criteria included indication for immediate delivery on admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal hypoxia/distress), fetal malformations, multiple gestation, and maternal immunosuppressive disease. Considering future sample size calculation based upon assumed differences between groups regarding latency and infection, we aimed a sample of 30 participants.
Randomization - A pilot unblinded randomized controlled trial (RCT) in a 1:1 allocation ratio between two groups (complete bed rest versus activity restriction after PPROM). Simple random allocation sequence was generated by the investigators and implemented by sequentially numbered sealed envelopes. Participants were enrolled by physicians after hospital admission and written informed consent was obtained before randomization. The trial was conducted in a single tertiary center of the Portuguese national health system after approval by its ethical committee.
Statistical analysis - An intention-to-treat analysis was performed with a significance level of 5%.
日期
| 最后验证: | 12/31/2018 |
| 首次提交: | 11/22/2018 |
| 提交的预估入学人数: | 01/20/2019 |
| 首次发布: | 01/23/2019 |
| 上次提交的更新: | 01/27/2019 |
| 最近更新发布: | 01/29/2019 |
| 实际学习开始日期: | 12/31/2011 |
| 预计主要完成日期: | 11/30/2017 |
| 预计完成日期: | 12/31/2017 |
状况或疾病
干预/治疗
Behavioral: Complete bed rest
Behavioral: Activity restriction group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Complete bed rest Participants on complete bed rest group kept antepartum confinement to bed with toileting restricted to bedpan use. Participants in this group received prophylactic subcutaneous enoxaparin (40mg/day). | Behavioral: Complete bed rest Patients in this group received standard care for PPROM according to the institution protocol, including antepartum confinement to bed. |
| Experimental: Activity restriction group Activity restriction group had motion limited to bathroom privileges and walks to the ward canteen four times per day. | Behavioral: Activity restriction group Patients in this group received standard care for PPROM according to the institution protocol but to had bathroom privileges and walks to the ward canteen four times per day. |
资格标准
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - single pregnancies AND - PPROM at 24+0-33+6 weeks of gestation AND - admitted to our tertiary center. Exclusion Criteria: - indication for immediate delivery on admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal hypoxia/distress) - fetal malformations - multiple gestation - maternal immunosuppressive disease |
结果
主要结果指标
1. Latency time [From preterm premature rupture of the membranes until delivery, estimated average time of one week]
2. Chorioamnionitis [From preterm premature rupture of the membranes until delivery, estimated average time of one week]
