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RecruitingNCT02997345Updated Mar 16, 2026

PPROM Registry (Preterm Premature Rupture of Membranes)

An observational study in Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes and Oligohydramnios, sponsored by American Alliance for pProm Support. Recruiting at 1 site in United States. Open to female participants aged 14 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by American Alliance for pProm Support · Observational

From the registry’s dates

  • Started Jul 2013; still recruiting 13 years 4 months later.
Study type
Observational
Model
Ecologic or community
Time perspective
Other
Enrollment
3,000
Ages
14 Years to 55 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • PPROM
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In context

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 122 across 36 observational studies indexed under Fetal Membranes, Premature Rupture.

Browse Fetal Membranes, Premature Rupture studies →

Lead sponsor

This is the only study on the registry with American Alliance for pProm Support as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those without a clinical diagnosis or confirmation of PPROM in pregnancy
  • Diagnosis of PROM beyond 37 weeks of pregnancy
05

Study design

Observational model
Ecologic or community
Time perspective
Other
Enrollment
3,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • PPROM (Preterm Premature Rupture of Membranes)

    PPROM / Preterm Premature Rupture of Membranes \<37 weeks

    Other: There is no intervention associated with this study.

Interventions

  • OtherThere is no intervention associated with this study.

    There is no intervention associated with this study.

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What researchers measure

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

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Study locations

1 of 1 sites recruiting
  • Www.Aapprom.Org/the-Registry
    Denver, Colorado 80202, United States
    Recruiting
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References and documents

Related links

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02997345
Lead sponsor
American Alliance for pProm Support
Responsible party
Erin Thatcher (Director, American Alliance for pProm Support) — Principal investigator
First posted
Dec 20, 2016
Start date
Jul 2013
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Mar 16, 2026

Study contacts

Erin Thatcher
Contact
(740) 837-7766

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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