PPROM Registry (Preterm Premature Rupture of Membranes)

NCT ID: NCT02997345

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2025-12-31

Brief Summary

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Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.

Detailed Description

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Detailed Description

Preterm Premature Rupture of Membranes (pProm) is a factor in 40% of preterm births. The earlier in pregnancy pProm occurs, the greater the potential latency period. Threats to the pregnancy include placental abruption, umbilical cord prolapse, infection, and insufficient pulmonary development, and preterm delivery. Management of pProm may include immediate delivery, induction, or expectant management.

It is still unclear what is considered best practice for the course of treatment in pProm pregnancies and post- delivery care of pProm babies in Neonatal Intensive Care Units (NICU), as well as the long term outcomes of pProm survivors. Unfortunately, there are few recent studies available for review and those that exist often do not reflect the current treatments or innovations that have taken place, especially in neonatal care. Many of the studies available focusing on pProm have very small sample sizes, as well as very short follow-up post-delivery, resulting in a wide range of reported outcomes, especially regarding the morbidity and mortality associated with pProm.

The pProm registry is the first of its kind and will provide a large cohort of data for study. The purpose of this registry is to better understand pregnancies and births impacted by pProm. This includes how pProm is managed in pregnancy and in how pProm neonates are cared for in the NICU; identifying trends in expectant management, and to detect short term and long term outcomes of those affected.

Conditions

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Fetal Membranes, Premature Rupture Preterm Premature Rupture of the Membranes Oligohydramnios Premature Birth

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

OTHER

Study Groups

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PPROM (Preterm Premature Rupture of Membranes)

PPROM / Preterm Premature Rupture of Membranes \<37 weeks

There is no intervention associated with this study.

Intervention Type OTHER

There is no intervention associated with this study.

Interventions

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There is no intervention associated with this study.

There is no intervention associated with this study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy

Exclusion Criteria

* Those without a clinical diagnosis or confirmation of PPROM in pregnancy
* Diagnosis of PROM beyond 37 weeks of pregnancy
Minimum Eligible Age

14 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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American Alliance for pProm Support

OTHER

Sponsor Role lead

Responsible Party

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Erin Thatcher

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Www.Aapprom.Org/the-Registry

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Thatcher

Role: CONTACT

(740) 837-7766

Facility Contacts

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Erin

Role: primary

740-837-7766

Related Links

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Other Identifiers

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tpr072013

Identifier Type: -

Identifier Source: org_study_id

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