Domiciliary Versus Hospital Management of PPROM (PPROM)

Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)

This study is designed to compare efficacy & safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.

Study Overview

• Status: Completed
• Conditions: Preterm Premature Rupture of Membrane
• Intervention / Treatment: Other: Clinical follow up

Detailed Description

Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management is developing more and more in obstetrics, with psychological benefits for patients as well as other financial benefits. Reliable discharge criteria have been mentioned by few studies for patients with PPROM. Studies had shown that domiciliary care management in a context of PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the latency period. However, eligibility criteria for domiciliary care management were heterogeneous

Aim of The Work: The aim of this study is to compare efficacy & safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.

Patients & Methods: The current trial was conducted at Ain Shams University Maternity Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic & emergency room and included in the study. Then, they were randomized into two groups; group (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby was assessed as a primary outcome and other maternal, fetal & neonatal complications were recorded & moreover latency period, mode of delivery & preference of care were assessed

• Study Type: Observational
• Enrollment (Actual): 3662

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Faculty of Medicine - Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study will include 3662 women with a history of preterm prelabor rupture of the membranes

Description

Inclusion Criteria include women with PPROM ≥28 weeks & <37 weeks with no signs of intra-amniotic infection & membranes rupture is confirmed by a sterile speculum examination and decrease amniotic fluid on ultrasound with singleton, viable, cephalic presenting fetus, morphologically normal fetus by ultrasound & reactive fetal heart rate tracing with no evidence of meconium-stained liquor

Exclusion Criteria:

• Query PPROM: A history of PPROM with no pooling of amniotic fluid from the cervix on a sterile speculum examination
• Maternal comorbidities (Diabetes mellitus, hypertension, etc.)
• Patients with placenta previa
• Amniotic fluid pocket on ultrasound < 2x2 cm
• Logistic problems interfering with follow-up
• Inability to check temperature every six hours, with parameters for notifying their clinician (temperature ≥38°C)
• Non-Dependable transportation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group (D): Planned domiciliary care.; Patients within this group will be counseled for home care with self-monitoring for any symptoms suggestive of preterm labor, maternal or fetal distress.	Other: Clinical follow up; Patients recruited in this study commenced antibiotic treatment according to the recent guidelines : Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner); Penicillin may be used in patients who can't tolerate erythromycin; In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.
Group (H): Planned hospital care.; Patients within this group will be admitted at hospital for close monitoring of maternal & fetal wellbeing & finally the neonatal outcome	Other: Clinical follow up; Patients recruited in this study commenced antibiotic treatment according to the recent guidelines : Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner); Penicillin may be used in patients who can't tolerate erythromycin; In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Take-home baby	this outcome is the best indicator of success of the management plan when the outcome is alive & well baby	2 years

Collaborators and Investigators

• Sponsor: Ahmed Mohammed Selim

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 20, 2020

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: PPROM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all statistical methods, results of the study ,discussion & recommendations
• IPD Sharing Time Frame: onset of January, 2022 (6 months after publication)
• IPD Sharing Access Criteria: sponsor e.mail & the sponsor organisation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No