Recruiting

Observational Study

Sponsor:

American Alliance for pProm Support

Code:

NCT02997345

Conditions

Fetal Membranes, Premature Rupture

Preterm Premature Rupture of the Membranes

Oligohydramnios

Premature Birth

Eligibility Criteria

Sex: Female

Age: 14 - 55

Healthy Volunteers: Accepted

Interventions

There is no intervention associated with this study.

Study Details

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.

Conditions

Fetal Membranes, Premature Rupture

Preterm Premature Rupture of the Membranes

Oligohydramnios

Premature Birth

Study ID

NCT02997345

Start date

Jul, 2013

Status verified date

Mar, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

PPROM (Preterm Premature Rupture of Membranes)

PPROM / Preterm Premature Rupture of Membranes <37 weeks

Interventions

There is no intervention associated with this study.

There is no intervention associated with this study.

Primary outcome measure

  • Early Neonatal Mortality Rate [ Time Frame: 28 days post delivery ]

Central Contacts and Locations

Central contacts

Erin Thatcher

(740) 837-7766

Locations

Www.Aapprom.Org/the-Registry

Recruiting

Denver, Colorado, United States, 80202

Contacts

Erin

740-837-7766erin@aapprom.org

More Information

Sponsor

American Alliance for pProm Support

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • PPROM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by American Alliance for pProm Support on 2026-03-16.