Recruiting

Digital vs. Speculum

Sponsor:

Washington University School of Medicine

Code:

NCT05773014

Conditions

PPROM

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Speculum Exams

Digital Exams

Study Details

Brief summary:

After preterm prelabor rupture of membranes (PPROM)\[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy\], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby), and placental abruption (separation of the placenta from wall of the uterus). When evaluation of cervical dilation is clinically indicated, obstetricians traditionally perform sterile speculum exams due to concern for decrease in pregnancy latency (length of time between breaking the water and delivery) with sterile digital exams in retrospective studies. These studies are concerning, however, by the indications for the exams and are at risk for confounding by indication. This is a randomized, non-inferiority trial to examine if sterile digital versus speculum exams effect latency of pregnancy in patients with PPROM.

Conditions

PPROM

Study ID

NCT05773014

Start date

Mar 27, 2023

Status verified date

Dec, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Speculum Exams

If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a sterile speculum exam. A sterile speculum with lubricating jelly will be inserted into the patient's vagina to visualize the cervix and visually estimate cervical dilation and effacement.

active comparator: Digital Exams

If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a digital exam. The provider will wear sterile gloves with lubricating jelly and will palpate the cervix to assess cervical dilation, effacement, and station.

Interventions

Speculum Exams

Same as arm

Digital Exams

Same as arm

Primary outcome measure

  • Pregnancy latency [ Time Frame: up to 10 weeks ]

Central Contacts and Locations

Central contacts

Nandini Raghuraman, MD

3142732939nraghuraman@wustl.edu

Jaime Strickland

3147471390jaime.strickland@wustl.edu

Locations

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Nandini Raghuraman, MD

nraghuraman@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jan 5, 2026

Last verified

Dec, 2025

Keywords

  • PPROM
  • speculum exam
  • preterm birth
  • preterm prelabor rupture of membranes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-01-05.