Bed Rest After Preterm Premature Rupture of the Membranes

NCT03814278 | Completed

• 1 other identifier: RPM-PT_Estudo_Repouso
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Preterm Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Complete bed rest

EXPERIMENTAL

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

Activity restriction group

EXPERIMENTAL

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

Behavioral: activity restriction

Interventions

complete bed rest BEHAVIORAL

Patients in this group received standard care for PPROM according to the institution protocol, including antepartum confinement to bed.

Complete bed rest

activity restriction BEHAVIORAL

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.

Activity restriction group

Eligibility Criteria

• Gender Eligibility Details: Patient eligibility is based on gender identity because we will include only pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• single pregnancies AND
• PPROM at 24+0-33+6 weeks of gestation AND
• admitted to our tertiary center.

You may not qualify if:

• indication for immediate delivery on admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal hypoxia/distress)
• fetal malformations
• multiple gestation
• maternal immunosuppressive disease

Sponsors & Collaborators

• Centro Hospitalar Lisboa Norte: lead

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: January 24, 2019
• Study Start: January 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01