Bed Rest After Preterm Premature Rupture of the Membranes

Centro Hospitalar Lisboa Norte

Status: Completed

Conditions: Preterm Premature Rupture of Membrane

Treatments: Behavioral: activity restriction; Behavioral: complete bed rest

Study type: Interventional

Funder types: Other

Identifiers

NCT03814278

RPM-PT_Estudo_Repouso

Details and patient eligibility

About

Antepartum bed rest is widely prescribed after preterm premature rupture of the membranes (PPROM), although its effectiveness to prevent preterm birth has not been demonstrated. This pilot randomized controled trial (RCT) aims to access the impact of bed rest in maternal and neonatal outcomes in pregnancies complicated by premature rupture of the membranes.

Full description

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%.

Enrollment: 32 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Complete bed rest

Experimental group

Description:

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).

Treatment:

Behavioral: complete bed rest

Activity restriction group

Experimental group

Description:

Activity restriction group had motion limited to bathroom privileges and walks to the ward canteen four times per day.

Treatment:

Behavioral: activity restriction