Outpatient Management of Preterm Prelabor Rupture of Membranes

NCT ID: NCT05755841

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-01

Brief Summary

Home-care management is possible if patients are clinically stable forty-eight hours after Preterm Prelabour Rupture of the membrane with no clinical or biological signs suggestive of intrauterine infection. Several retrospective studies have highlighted the safety of such outpatient management for women with nonthreatening Preterm Prelabour Rupture of the membrane. This prospective cohort study will compare inpatient versus outpatient management of preterm Prelabour rupture of membrane regarding latency, intra-amniotic infection, birth weight, and neonatal complications at 28 to 34 weeks of gestation after 48 hours of admission to Ain-Shams University Maternity Hospital.

Detailed Description

The fetal membranes are made of two histological layers, the amnion in contact with the amniotic fluid, and the chorion in contact with the maternal decidua. They engrave the fetus during pregnancy and serve as a barrier between the maternal and fetal compartments, supplying both physicochemical and biochemical defense against external shocks and rising vaginal flora bacteria.

Membrane rupture is a biochemical phenomenon that happens towards the conclusion of birth. The programmed weakening of the Para cervical region, marked by collagen remodeling and apoptosis coupled with uterine contractions that produce stretching and shearing forces, contributes to the breakup of the membranes.

The rupture that happens before initiating contractions in 10% of pregnancies is called "Prelabour membrane rupture" (PROM). About 3% of women undergo Prelabour Rupture of the membrane before 37 weeks of birth, which is considered preterm pre-labor membrane breakup (PPROM). This condition is responsible for one-third of preterm births and raises perinatal morbidity and mortality primarily due to the risk of intrauterine infection, which may lead to early neonatal infection, necrotizing enterocolitis, and uterine fetal death

In spite of major progress in antenatal management over the past three decades, Prelabour membrane rupture and prenatal birth are still common. About 50 percent of women with Preterm Prelabour Rupture of the membrane (<37 WG) bear children within 24-48 hours after rupture and 70 percent to 90 percent within 7 days. Patients with Preterm Prelabour Rupture of the membrane need clinical treatment in a hospital that has the required services for premature babies. When the point of fetal viability is met, Preterm Prelabour Rupture of the membrane is initially hospital-based and consists of antibiotic prophylaxis and corticosteroids for fetal lung maturation. The key surveillance priorities are the diagnosis and treatment of maternal and fetal complications, in particular intrauterine infections. Home-care treatment is possible if patients are clinically stable 48 hours post Prelabour Rupture of the membrane with no clinical or biological symptoms of intrauterine infection. The protection of such outpatient management for women with non-threatening Preterm Prelabour Rupture of the membrane has been illustrated in many retrospective studies.

Home-care inclusion requirements are based on gestational age, lack of chorioamnionitis, physiological reliability at least 72 hours after Preterm Prelabour Rupture of the membrane (up to 7 days depending on the study), cervical dilation, and patient at home. The time between membrane breakup and labor initiation, referred to as latency, is stated to be correlated with neonatal morbidity and mortality. While certain factors, such as gestational age at Preterm Prelabour Rupture of the membrane, cervical dilation, parity, twin pregnancy, and chorioamnionitis, have been reported to affect latency in the literature, the time between rupture and delivery remains difficult to predict. Awareness of short-term predictive variables could optimize the length of hospital stay and help forecast the likelihood of adverse perinatal outcomes.

Conditions

Management of Preterm Prelabor Rupture of Membranes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Outpatient management of preterm prelabor rupture of membranes

Outpatient management of preterm prelabor rupture of membranes

Intervention Type: OTHER

Patients who will be managed as outpatients will be discharged after 48 hours of hospitalization with the following management:

• Twice weekly fetal cardiotocography.
• Complete blood count once a week.
• A weekly clinical and ultrasound examination.

2

Inpatient management of preterm prelabor rupture of membranes

Inpatient management of preterm prelabor rupture of membranes

Intervention Type: OTHER

In the Inpatient Care Policy group, the same protocol as outpatient group will be applied, but the patient will not be discharged until delivery.

Interventions

Outpatient management of preterm prelabor rupture of membranes

Patients who will be managed as outpatients will be discharged after 48 hours of hospitalization with the following management:

• Twice weekly fetal cardiotocography.
• Complete blood count once a week.
• A weekly clinical and ultrasound examination.

Intervention Type: OTHER

Inpatient management of preterm prelabor rupture of membranes

In the Inpatient Care Policy group, the same protocol as outpatient group will be applied, but the patient will not be discharged until delivery.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Gestational age 28-34 weeks as calculated from the Last Menstrual period, Ultrasound examination in early 2nd trimester at 14 weeks, or first trimetric ultrasound.

2. Confirmed preterm Prelabour rupture of membranes using a Sterile Cusco speculum examination, definitive history of gush of watery discharge or ultrasound measurement of the deepest vertical pocket <2cm.

Exclusion Criteria

1. Mutiple pregnancy

2. Cases with congenital fetal malformations conditioning prognosis

3. Preterm prelabor rupture of membranes associated with preeclampsia, Diabetes mellitus, Systemic lupus erythematosus, long term steroid therapy, Renal/hepatic impairment

4. Preterm Prelabour Rupture of membrane-associated with antepartum hemorrhage or asymptomatic Placenta Previa

5. Past history of classic Cesarean section

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohammed Elmaraghy

Lecturer in Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AinShams university maternity hospital

Cairo, , Egypt

Countries

Egypt

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Other Identifiers

9

Identifier Type: -

Identifier Source: org_study_id