Outpatient Management of Preterm Prelabor Rupture of Membranes

March 20, 2023 updated by: Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital

Inpatient Versus Outpatient Management of Preterm Prelabour Rupture of Membrane. A Prospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • AinShams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women admitted to Ain Shams University Maternity Hospital due to preterm prelabor rupture of membranes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Outpatient management of preterm prelabor rupture of membranes
Other: 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.
2
Inpatient management of preterm prelabor rupture of membranes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latency period
Time Frame: From the time of membrane rupture till the time of delivery
the interval between rupture of the membranes and the onset of labor.
From the time of membrane rupture till the time of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraamniotic infection
Time Frame: From the time of membrane rupture till the time of delivery

▪ Intra-amniotic infection, will be diagnosed clinically :

  • Maternal fever >38°c.
  • Purulent cervical discharge.
  • Fetal tachycardia>160 beats/min.
From the time of membrane rupture till the time of delivery
Birth weight
Time Frame: First 24 hours after delivery
Neonatal birth weight
First 24 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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