PPROM Registry (Preterm Premature Rupture of Membranes) | NCT02997345

Studies
PPROM Registry (Preterm Premature Rupture of Membranes)

NCT02997345

Sponsor

American Alliance for pProm Support

Status

Recruiting

Last Update Posted

Mar 16, 2026Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

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

Interventions

There is no intervention associated with this study.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Oct 18, 2016

First Submission Date that Met QC Criteria

Dec 15, 2016

First Posted Date

Dec 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2026

Last Update Posted Date

Mar 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erin Thatcher, Director, American Alliance for pProm SupportPrincipal Investigator

Lead Sponsor

American Alliance for pProm SupportOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PPROM (Preterm Premature Rupture of Membranes)		PPROM / Preterm Premature Rupture of Membranes <37 weeks	Other: There is no intervention associated with this study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention associated with this study.	Other	There is no intervention associated with this study.	PPROM (Preterm Premature Rupture of Membranes)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Stillbirth / Perinatal Mortality Rate		Upon delivery

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erin Thatcher	Contact	(740) 837-7766

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Www.Aapprom.Org/the-Registry	Recruiting	Denver	Colorado	80202	United States

Label	URL
PPROM Registry	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005322	Fetal Membranes, Premature Rupture
C563032	Preterm Premature Rupture of the Membranes
D016104	Oligohydramnios
D047928	Premature Birth

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided