PPROM Registry (Preterm Premature Rupture of Membranes)

NCT02997345 | Recruiting DMC

• 1 other identifier: tpr072013
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

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

Keywords

PPROM

Outcome Measures

Primary Outcomes (1)

• Early Neonatal Mortality Rate

  28 days post delivery

Secondary Outcomes (1)

• Stillbirth / Perinatal Mortality Rate

  Upon delivery

Other Outcomes (1)

• Review of Socio-Economic Factors in pProm

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

Study Arms (1)

PPROM (Preterm Premature Rupture of Membranes)

PPROM / Preterm Premature Rupture of Membranes \<37 weeks

Other: There is no intervention associated with this study.

Interventions

There is no intervention associated with this study. OTHER

There is no intervention associated with this study.

PPROM (Preterm Premature Rupture of Membranes)

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• American Alliance for pProm Support: lead

Study Sites (1)

Www.Aapprom.Org/the-Registry

Denver, Colorado, 80202, United States

RECRUITING

Related Links

• PPROM Registry

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature

Central Study Contacts

Erin Thatcher

CONTACT

(740) 837-7766

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: December 20, 2016
• Study Start: July 1, 2013
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)