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Preterm Prelabor Rupture of Membranes (PPROM)NCT07841587

Prediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes

An observational study of Preterm Prelabor Rupture of Membranes (PPROM), run by Ain Shams Maternity Hospital at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Oct 2026to Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Pregnant women with preterm prelabor rupture of membranes presenting to Ain Shams University Maternity Hospital.

Who may be able to join

  • Gestational age 28-34 weeks at membrane rupture
  • Presenting to the hospital within 24 hours of PPROM

Who cannot join

  • Women with contraindications to conservative management. Clinical chorioamnionitis at presentation. Patients presenting in labor Intrauterine fetal death
  • Medical/Obstetric indications for immediate delivery at presentation:
  • Severe preeclampsia. Bleeding: placenta previa or placental abruption
  • Women with other risk factors for preterm birth. Fetal growth restriction with lost end-diastolic flow in umbilical artery Known uterine anomalies Multifetal gestation
  • Previous uterine surgery (e.g., myomectomy, classical cesarean section)
  • Morbidly obese women rendering sonographic assessment inaccurate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed ElMaraghy, M.D, contact

+201010370980

ahmedelmaraghy@med.asu.edu.eg

Hamdy Alqenawy, M.D., contact

hamdybakry@med.asu.edu.eg

Egypt1 site
  • Ainshams University maternity hospital

    Cairo

    Ahmed M ElMaraghy, ahmedelmaraghy@med.asu.edu.eg

Other trials in Egypt

About this study

Official title: Myometrial Thickness as a Predictor of Latency Interval in Preterm Prelabor Rupture of Membranes: A Prospective Cohort Study

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.

Read the detailed description

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.

Keywords
Myometrial thickness - Latency interval, Preterm prelabor rupture of membranes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: the period from membrane rupture to 24 hours after membrane rupture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07841587
Sponsor's protocol ID
19
Status last verified
Oct 2026
First submitted
20 Sep 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.

    PubMed 32080050
  • Anil, A., Srinivas, S. B., Hebbar, S., & Pai, M. V. (2020). The upper and lower uterine segment thickness ratio: A simple sonographic tool to triage for preterm delivery among women with threatened preterm labor. Current Women's Health Reviews, 16(3), 236-243. https://doi.org/10.2174/1573404816666200309153236

  • Atarjavdan L, Khazaeipour Z, Shahbazi F. Correlation of myometrial thickness and the latency interval of women with preterm premature rupture of the membranes. Arch Gynecol Obstet. 2011 Dec;284(6):1339-43. doi: 10.1007/s00404-011-1841-x. Epub 2011 Feb 5.

    PubMed 21298281
  • Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.

    PubMed 30389451
  • Feduniw S, Pruc M, Ciebiera M, Zeber-Lubecka N, Massalska D, Zgliczynska M, Pawlowska A, Szarpak L. Biomarkers for Pregnancy Latency Prediction after Preterm Premature Rupture of Membranes-A Systematic Review. Int J Mol Sci. 2023 Apr 28;24(9):8027. doi: 10.3390/ijms24098027.

    PubMed 37175733
  • Gupta R, Nagarsenkar A. Using Sonographically Estimated Myometrial Thickness in Prediction of Latency Interval in Cases of Preterm Premature Rupture of Membranes (PPROM). J Obstet Gynaecol India. 2016 Dec;66(6):431-435. doi: 10.1007/s13224-015-0711-z. Epub 2015 Jul 11.

    PubMed 27821983
  • Park JH, Bae JG, Chang YS. Neonatal Outcomes according to the Latent Period from Membrane Rupture to Delivery among Extremely Preterm Infants Exposed to Preterm Premature Rupture of Membrane: a Nationwide Cohort Study. J Korean Med Sci. 2021 Apr 12;36(14):e93. doi: 10.3346/jkms.2021.36.e93.

    PubMed 33847083
  • Ronzoni S, Boucoiran I, Yudin MH, Coolen J, Pylypjuk C, Melamed N, Holden AC, Smith G, Barrett J. Guideline No. 430: Diagnosis and management of preterm prelabour rupture of membranes. J Obstet Gynaecol Can. 2022 Nov;44(11):1193-1208.e1. doi: 10.1016/j.jogc.2022.08.014. Epub 2022 Oct 2.

    PubMed 36410937
  • Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabedian C, Azria E, Tessier V, Senat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2.

    PubMed 30870741
  • Shynlova O, Nadeem L, Zhang J, Dunk C, Lye S. Myometrial activation: Novel concepts underlying labor. Placenta. 2020 Mar;92:28-36. doi: 10.1016/j.placenta.2020.02.005. Epub 2020 Feb 4.

    PubMed 32056784
  • Singh, S., Sharma, R., Gupta, N., & Suneja, A. (2021). Sonographic evaluation of myometrial thickness at different gestations for prediction of labor in preterm premature rupture of membranes. Journal of South Asian Federation of Obstetrics and Gynaecology, 13(6), 415-421. https://doi.org/10.5005/jp-journals-10006-1981

  • Tchirikov M, Schlabritz-Loutsevitch N, Maher J, Buchmann J, Naberezhnev Y, Winarno AS, Seliger G. Mid-trimester preterm premature rupture of membranes (PPROM): etiology, diagnosis, classification, international recommendations of treatment options and outcome. J Perinat Med. 2018 Jul 26;46(5):465-488. doi: 10.1515/jpm-2017-0027.

    PubMed 28710882
  • Thomson AJ; Royal College of Obstetricians and Gynaecologists. Care of Women Presenting with Suspected Preterm Prelabour Rupture of Membranes from 24+0 Weeks of Gestation: Green-top Guideline No. 73. BJOG. 2019 Aug;126(9):e152-e166. doi: 10.1111/1471-0528.15803. Epub 2019 Jun 17. No abstract available.

    PubMed 31207667

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Prelabor Rupture of Membranes (PPROM), run by Ain Shams Maternity Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed ElMaraghy, M.D, (+201010370980, ahmedelmaraghy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myometrial thickness as a predictor of latency interval in patients with preterm prelabor rupture of membranes (time frame: the period from membrane rupture to 24 hours after membrane rupture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07841587, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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