Domiciliary Versus Hospital Management of PPROM

Preterm Premature Rupture of Membrane Clinical Trial

— PPROM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413019
• Other study ID #: PPROM
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: October 20, 2020

Study information

• Verified date: January 2021
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3662
• Est. completion date: October 20, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine - Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Mohammed Selim

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Take-home baby	this outcome is the best indicator of success of the management plan when the outcome is alive & well baby	2 years