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PPROM Registry (Preterm Premature Rupture of Membranes)

Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02997345
Enrollment
3000
Registered
2016-12-20
Start date
2013-07-01
Completion date
2030-12-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PPROM

Brief summary

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

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.

Interventions

OTHERThere is no intervention associated with this study.

There is no intervention associated with this study.

Sponsors

American Alliance for pProm Support
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Early Neonatal Mortality Rate28 days post delivery

Secondary

MeasureTime frame
Stillbirth / Perinatal Mortality RateUpon delivery

Countries

United States

Contacts

CONTACTErin Thatcher
(740) 837-7766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026