PPROM Registry (Preterm Premature Rupture of Membranes)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Fetal Membranes, Premature Rupture; Oligohydramnios; Preterm Premature Rupture of the Membranes
• Intervention / Treatment: Other: There is no intervention associated with this study.

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Erin Thatcher; Phone Number: (740) 837-7766

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80202
      • Recruiting
      • Www.Aapprom.Org/the-Registry
      • Contact: Erin; Phone Number: 740-837-7766; Email: erin@aapprom.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PPROM (Preterm Premature Rupture of Membranes); PPROM / Preterm Premature Rupture of Membranes <37 weeks	Other: There is no intervention associated with this study.; There is no intervention associated with this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Early Neonatal Mortality Rate	28 days post delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Stillbirth / Perinatal Mortality Rate	Upon delivery

Other Outcome Measures

Outcome Measure	Time Frame
Review of Socio-Economic Factors in pProm	Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months

Collaborators and Investigators

• Sponsor: American Alliance for pProm Support

Publications and helpful links

Helpful Links

• PPROM Registry

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (ESTIMATE): December 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: PPROM
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Oligohydramnios; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: tpr072013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED