An observational study in Preterm Prelabor Rupture of Membranes (PPROM), sponsored by Ain Shams Maternity Hospital. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Ain Shams Maternity Hospital · Observational
Prediction of latency interval in Preterm prelabor rupture of membranes (PPROM) remains challenging in clinical practice, Myometrial thickness (MT) has emerged as a potential ultrasound marker for predicting the risk of preterm labor.
This study aims to prospectively evaluate the correlation between MT measurements at multiple uterine sites and latency interval in women with PPROM.
PPROM is a major obstetric complication, occurring in approximately 3% of pregnancies and accounting for 30-40% of preterm births worldwide. It is defined as rupture of the fetal membranes before the onset of labor and prior to 37 weeks of gestation, creating a clinical dilemma that balances the risks of prematurity against the dangers of prolonged membrane rupture. The condition carries significant perinatal morbidity and mortality, including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal sepsis, alongside maternal complications such as chorioamnionitis and postpartum hemorrhage.
The latency period, defined as the interval between membrane rupture and delivery, is a critical determinant of neonatal outcomes. A longer latency permits completion of antenatal corticosteroid therapy for fetal lung maturation and antibiotic prophylaxis, thereby improving neonatal prognosis. Conversely, prolonged latency increases the risk of ascending infection, chorioamnionitis, and placental abruption, necessitating careful and individualized management, Current evidence indicates that approximately 50% of affected women deliver within 48 hours, and 70-90% within one week of membrane rupture, although latency may occasionally extend for several weeks in cases of very early PPROM according to recommendations of the American College of Obstetricians and Gynecologists.
Standard management between 24 and 34 weeks includes hospitalization, antibiotic prophylaxis, antenatal corticosteroids, and magnesium sulfate for neuroprotection before 32 weeks, alongside close maternal-fetal surveillance. Despite these well-established interventions, accurate prediction of latency duration remains a significant clinical challenge. Traditional predictors such as gestational age at rupture, amniotic fluid volume, cervical length, fetal fibronectin, and inflammatory markers have demonstrated variable sensitivity and specificity across different populations, limiting their widespread clinical utility.
Ultrasonographic assessment has become integral to PPROM management, and recent attention has focused on myometrial thickness (MT) as a potential non-invasive predictor of labor onset and delivery timing. The myometrium undergoes dynamic structural and functional changes throughout pregnancy, with thickness variations reflecting uterine contractility patterns, inflammatory responses, and the risk of imminent delivery. Studies in women with threatened preterm labor have shown that increased MT particularly at the lower uterine segment correlates with heightened uterine activity and a shorter interval to delivery . Ultrasonography provides a non-invasive method for assessing uterine morphology and myometrial activity, with increasing interest in its potential role in predicting the onset of preterm labor.
Despite encouraging preliminary findings, evidence regarding the predictive value of MT in women with PPROM remains limited, and further prospective studies are required before its routine clinical application. Furthermore, in middle-income countries, such as Egypt, where preterm birth remains a major contributor to neonatal morbidity and mortality, the development of accessible, affordable, and non-invasive predictive tools for women with PPROM is of particular clinical importance. The wide availability of ultrasound equipment makes MT measurement a feasible and cost-effective addition to routine PPROM assessment, without requiring specialized biochemical assays or advanced technology.
This study therefore aims to prospectively evaluate the association between MT at multiple uterine sites and the latency interval in women with PPROM. Cut-off values predictive of imminent delivery can be incorporated into clinical management algorithms for this challenging obstetric condition.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's planned enrollment of 50 is below the median of 122 across 36 observational studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.
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Pregnant women with preterm prelabor rupture of membranes presenting to Ain Shams University Maternity Hospital.
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Exclusion Criteria:
Medical/Obstetric indications for immediate delivery at presentation:
Severe preeclampsia. Bleeding: placenta previa or placental abruption
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
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Myometrial thickness as a predictor of latency interval in patients with preterm prelabor rupture of membranes
Correlation between myometrial thickness at each uterine measurement site and latency interval in patients with preterm prelabor rupture of membranes
Time frame: the period from membrane rupture to 24 hours after membrane rupture
Plan to share: No
Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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