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NCT Number: NCT02997345

PPROM Registry (Preterm Premature Rupture of Membranes)

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.

Recruiting

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Key information

Age range

14 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Www.Aapprom.Org/the-Registry

Denver, Colorado, 80202, United States

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There is no intervention associated with this study.

Other

There is no intervention associated with this study.

Primary outcomes

  1. Early Neonatal Mortality Rate

    Time frame: 28 days post delivery

Secondary outcomes

  1. Stillbirth / Perinatal Mortality Rate

    Time frame: Upon delivery

Other outcomes

  1. Review of Socio-Economic Factors in pProm

    Time frame: Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Thatcher

CONTACT

(740) 837-7766

Sponsors and collaborators

Lead sponsor

American Alliance for pProm Support

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Dec 20, 2016
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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