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PPROM Registry (Preterm Premature Rupture of Membranes)

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ClinicalTrials.gov Identifier: NCT02997345
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Erin Thatcher, American Alliance for pProm Support

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.

Condition or disease Intervention/treatment
Fetal Membranes, Premature Rupture Preterm Premature Rupture of the Membranes Oligohydramnios Premature Birth 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy
Study Start Date : July 2013
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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.




Primary Outcome Measures :
  1. Early Neonatal Mortality Rate [ Time Frame: 28 days post delivery ]

Secondary Outcome Measures :
  1. Stillbirth / Perinatal Mortality Rate [ Time Frame: Upon delivery ]

Other Outcome Measures:
  1. Review of Socio-Economic Factors in pProm [ Time Frame: Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997345


Contacts
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Contact: Erin Thatcher (740) 837-7766

Locations
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United States, Colorado
Www.Aapprom.Org/the-Registry Recruiting
Denver, Colorado, United States, 80202
Contact: Erin    740-837-7766    erin@aapprom.org   
Sponsors and Collaborators
American Alliance for pProm Support

Additional Information:
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Responsible Party: Erin Thatcher, Director, American Alliance for pProm Support
ClinicalTrials.gov Identifier: NCT02997345     History of Changes
Other Study ID Numbers: tpr072013
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Erin Thatcher, American Alliance for pProm Support:
PPROM
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Oligohydramnios
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries