Clinical trial Recruiting at 1 site Interventional Women only

Comparing digital and speculum exams for preterm prelabor rupture of membranes

Official title: Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial

Run by Washington University School of Medicine · NCT05773014 · Data updated 2026-11-12

This study is testing whether a digital exam or a speculum exam is better at helping pregnant women with early water breaking stay pregnant longer.

More PPROM trials

Quick facts

Study typeInterventional
SexWomen only
Enrollment86 (estimated)
SponsorWashington University School of Medicine
Academic / other
Locations1 site (St Louis, Missouri)
StatusRecruiting
StartedMarch 27, 2023
Main results expectedMarch 1, 2027
Study endsJuly 1, 2027
Registry record updatedJanuary 5, 2026
Trial IDNCT05773014 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pregnant individuals between 22 and 33 weeks of gestation who have clinically or laboratory-confirmed PPROM.

Probably not a fit

Patients with contraindications to digital examination or those who are COVID-19 positive upon admission may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of two different examination methods—digital exams and speculum exams—on the latency of pregnancy in patients diagnosed with preterm prelabor rupture of membranes (PPROM). Patients between 22 and 33 weeks of gestation who have confirmed PPROM will be randomly assigned to receive either type of exam to determine if one method is superior in prolonging the time before delivery. The study aims to address concerns regarding the impact of these exams on pregnancy outcomes and to provide evidence-based recommendations for clinical practice.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with PPROM, potentially extending pregnancy latency and improving neonatal outcomes.

How similar studies have gone: Previous studies have raised concerns about the impact of examination methods on pregnancy latency, but this specific randomized non-inferiority trial approach is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 22 weeks 0 days gestation to 33 weeks 5 days gestation
* Clinical or laboratory confirmation of PPROM
* At least 8 hours after rupture event
* English speaking

Notably, for patients \<25 weeks, approach for enrollment will be deferred until after the patient has discussed their desires for fetal resuscitation with the care team and are at a gestational age where they would desire this resuscitation.

Exclusion Criteria:

* Contraindications to digital examination
* COVID-19 positive on admission

Where it's running

  • Barnes Jewish Hospital
    St Louis, Missouri, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.