Bed Rest After Preterm Premature Rupture of the Membranes
キーワード
概要
説明
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%.
日付
| 最終確認済み: | 12/31/2018 |
| 最初に提出された: | 11/22/2018 |
| 提出された推定登録数: | 01/20/2019 |
| 最初の投稿: | 01/23/2019 |
| 最終更新が送信されました: | 01/27/2019 |
| 最終更新日: | 01/29/2019 |
| 実際の研究開始日: | 12/31/2011 |
| 一次完了予定日: | 11/30/2017 |
| 研究完了予定日: | 12/31/2017 |
状態または病気
介入/治療
Behavioral: Complete bed rest
Behavioral: Activity restriction group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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. |
適格基準
| 研究に適格な性別 | Female |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
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]
