Clinical trial NCT04413019: Domiciliary Versus Hospital Management of PPROM
Official title: Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Premature Rupture of Membrane
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 3662
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 3662 women with a history of preterm prelabor rupture of the membranes

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Take-home baby
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine - Ain Shams university
Study officials:
References: