Digital vs. Speculum Exams for PPROM

NCT05773014 | Recruiting DMC

• 1 other identifier: 202301012
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pregnancy latency

  time from admission to delivery

  up to 10 weeks

Secondary Outcomes (17)

• Maternal chorioamnionitis

  Prior to delivery

• Endomyometritis

  Within 2 weeks of delivery

• Maternal sepsis

  Within 2 weeks of delivery

• Maternal wound infections

  Within 2 weeks of delivery

• Maternal intensive care unit (ICU) admission

  Within 2 weeks of delivery

Study Arms (2)

Speculum Exams

ACTIVE COMPARATOR

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.

Procedure: Speculum Exams

Digital Exams

ACTIVE COMPARATOR

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.

Procedure: Digital Exams

Interventions

Speculum Exams PROCEDURE

Same as arm

Speculum Exams

Digital Exams PROCEDURE

Same as arm

Digital Exams

Eligibility Criteria

• Gender Eligibility Details: Patient must be pregnant
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63108, United States

RECRUITING

Related Publications (4)

• Sukcharoen N, Vasuratna A. Effects of digital cervical examinations on duration of latency period, maternal and neonatal outcome in preterm premature rupture of membranes. J Med Assoc Thai. 1993 Apr;76(4):203-9.

  PMID: 8113640 BACKGROUND

• Alexander JM, Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL, Das AF, Meis PJ, Moawad AH, Iams JD, Vandorsten JP, Paul RH, Dombrowski MP, Roberts JM, McNellis D. The impact of digital cervical examination on expectantly managed preterm rupture of membranes. Am J Obstet Gynecol. 2000 Oct;183(4):1003-7. doi: 10.1067/mob.2000.106765.

  PMID: 11035354 BACKGROUND

• Lewis DF, Major CA, Towers CV, Asrat T, Harding JA, Garite TJ. Effects of digital vaginal examinations on latency period in preterm premature rupture of membranes. Obstet Gynecol. 1992 Oct;80(4):630-4.

  PMID: 1407885 BACKGROUND

• Singhal, S., Puri, M., & Gami, N. (2011). An analysis of factors affecting the duration of latency period and its impact on neonatal outcome in patients with PPROM. International Journal of Infertility and Fetal Medicine. 2012; 3(3): 87-91.

  BACKGROUND

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Nandini Raghuraman, MD

CONTACT

3142732939; nraghuraman@wustl.edu

Jaime Strickland

CONTACT

3147471390; jaime.strickland@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 17, 2023
• Study Start: March 27, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)