Bed Rest After Preterm Premature Rupture of the Membranes

Preterm Premature Rupture of Membrane Clinical Trial

Official title:

A Pilot Randomized Controlled Trial On Complete Bed Rest Versus Activity Restriction After Preterm Premature Rupture of the Membranes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814278
• Other study ID #: RPM-PT_Estudo_Repouso
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: January 2018

Study information

• Verified date: January 2019
• Source: Centro Hospitalar Lisboa Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

Behavioral:
• complete bed rest
Patients in this group received standard care for PPROM according to the institution protocol, including antepartum confinement to bed.
• activity restriction
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency time	Time between preterm premature rupture of the membranes and delivery, in days	From preterm premature rupture of the membranes until delivery, estimated average time of one week
Primary	Chorioamnionitis	Incidence of clinical chorioamnionitis (defined as maternal fever plus leukocytosis and CRP elevation, or as maternal fever plus any two of the following: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent amniotic fluid)	From preterm premature rupture of the membranes until delivery, estimated average time of one week