Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 … (NCT03108404) | Clinical Trial Compass
TerminatedNot Applicable
Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation
Stopped: Recruitment difficulties
France34 participantsStarted 2017-01-19
Plain-language summary
Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and accounts for approximately 30 % of preterm births.
The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines. Conservative management to prolong a pregnancy is a classical approach to treat PPROM before 34 weeks' gestation in association with antibiotic therapy and corticosteroids.
Maternal and neonatal data were collected from maternal and newborns medical records.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women with PPROM between 22 weeks and 27 weeks and 6 days are eligible for this study
Exclusion Criteria:
* Therapeutic abortion / terminaison of pregnancy
* Intra uterine demise
* active labor with cervical dilatation of 3 cm with regular contractions.
* Triplet pregnancies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect how useful its findings might be for understanding my baby's prognosis?
2Since this study was focused on premature membrane rupture between 22 and 28 weeks, which is exactly my situation, are there any published results or predictive tools that came out of this research that you currently use to help estimate outcomes?
3The trial was trying to identify which factors before birth best predict neonatal death — based on what you know from this research or similar studies, which of my specific circumstances are you most concerned about when thinking about my baby's chances?
4Are there other completed studies or validated scoring tools for pregnancies with early premature rupture of membranes that your team already relies on, since this trial was terminated and may not have produced a full predictive score?
5Given that this trial was observational and focused on building a prediction tool rather than testing a treatment, what does that mean for how I should think about my care options right now — and are there active treatment trials I should know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The purpose was to determine which antepartum criteria were efficient to predict neonatal death, in order to create a predictive prognostic antenatal index of mortality.