PPROM Registry (Preterm Premature Rupture of Membranes)

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02997345
• Other study ID #: tpr072013
• Status: Recruiting
• Start date: July 2013
• Est. completion date: December 2025

Study information

• Verified date: February 2022
• Source: American Alliance for pProm Support
• Contact: Erin Thatcher
• Phone: (740) 837-7766
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• There is no intervention associated with this study.
There is no intervention associated with this study.

Locations

Country	Name	City	State
United States	Www.Aapprom.Org/the-Registry	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
American Alliance for pProm Support

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Review of Socio-Economic Factors in pProm		Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months
Primary	Early Neonatal Mortality Rate		28 days post delivery
Secondary	Stillbirth / Perinatal Mortality Rate		Upon delivery

External Links

•   PPROM Registry