Fetal Membranes, Premature RuptureNCT02997345
PPROM Registry (Preterm Premature Rupture of Membranes)
An observational study of Fetal Membranes, Premature Rupture and Preterm Premature Rupture of the Membranes, run by American Alliance for pProm Support at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes, Oligohydramnios
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy
Who may be able to join
- Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy
Who cannot join
- Those without a clinical diagnosis or confirmation of PPROM in pregnancy
- Diagnosis of PROM beyond 37 weeks of pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Erin Thatcher contact
United States1 site, 1 recruiting
- Recruiting
Www.Aapprom.Org/the-Registry
Denver, Colorado, 80202
Erin, 740-837-7766, erin@aapprom.org
About this study
Official title: 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.
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.
- Conditions
- Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes, Oligohydramnios, Premature Birth
- Being tested
- There is no intervention associated with this study.
- Keywords
- PPROM
- Medical subject headings
- Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes, Oligohydramnios, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention associated with this study.Other
There is no intervention associated with this study.
| Study group | Role | What they receive |
|---|---|---|
| PPROM (Preterm Premature Rupture of Membranes) | PPROM / Preterm Premature Rupture of Membranes <37 weeks Receives: Other: There is no intervention associated with this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Neonatal Mortality Rate
Measured: 28 days post delivery
Secondary outcomes (1)
Stillbirth / Perinatal Mortality Rate
Measured: Upon delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJul 2013
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- American Alliance for pProm Support
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Thatcher, American Alliance for pProm Support
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997345
- Sponsor's protocol ID
- tpr072013
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2016
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided