Domiciliary Versus Hospital Management of PPROM

NCT04413019 | Completed DMC

• 1 other identifier: PPROM
• Study Type: observational
• Target: 3,662
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

• Take-home baby

  this outcome is the best indicator of success of the management plan when the outcome is alive \& well baby

  2 years

Study Arms (2)

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

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

Interventions

Clinical follow up OTHER

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 (D): Planned domiciliary care.; Group (H): Planned hospital care.

Eligibility Criteria

• Gender Eligibility Details: pregnant women with rupture of the fetal membranes before 37 weeks of gestation
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Mohammed Selim: lead

Study Sites (1)

Faculty of medicine - Ain Shams university

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASelim

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: April 15, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 20, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: onset of January, 2022 (6 months after publication)
• Access Criteria: sponsor e.mail \& the sponsor organisation

Locations

EG (1)