Digital vs. Speculum Exams for PPROM (MOCA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: PPROM
• Intervention / Treatment: Procedure: Speculum Exams; Procedure: Digital Exams

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Burd, MD; Phone Number: (314) 362-7135; Email: burd.j@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Recruiting
      • Barnes Jewish Hospital
      • Contact: Julia Burd, MD; Email: burd.j@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Speculum Exams; Same as arm
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.	Procedure: Digital Exams; Same as arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy latency	time from admission to delivery	up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal chorioamnionitis	Per criteria of American College of Obstetricians and Gynecologists (ACOG): includes fever greater than or equal to 100.4 degrees Farenheit plus an additional sign such as fundal tenderness, white blood cell count >15, purulent vaginal discharge, fetal tachycardia, or placental culture with finding of chorioamnionitis. Suspected chorioamnionitis can also be diagnosed with isolated fever >102.2 degrees Fahrenheit	Prior to delivery
Endomyometritis	Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness	Within 2 weeks of delivery
Maternal sepsis	Defined as bacteremia with evidence of organ dysfunction	Within 2 weeks of delivery
Maternal wound infections	As diagnosed by the clinicians	Within 2 weeks of delivery
Maternal intensive care unit (ICU) admission	transfer to ICU or readmission to ICU	Within 2 weeks of delivery
Maternal death	Death of mother	Within 2 weeks postpartum
Composite neonatal morbidity	Need for respiratory support, neonatal sepsis, intraventricular hemorrhage, hypoxic ischemic encephalopathy, necrotizing enterocolitis, pneumonia, or neonatal demise	28 days of life
Length of neonatal intensive care unit (NICU) admission	From delivery until discharge from the NICU	Up to 1 year
Need for respiratory support	One or more of the following: Continuous positive airway pressure (CPAP) or high-flow nasal cannula for at least 2 consecutive hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 continuous hours, extracorporeal membrane oxygenation (ECMO), or mechanical ventilation	28 days of life
Neonatal sepsis at <72 hours of life	must be confirmed on blood culture	Within 72 hours of birth
Neonatal sepsis at >72 hours of life	must be confirmed on blood culture	28 days of life
Neonatal intraventricular hemorrhage (IVH)	Seen on head ultrasound	28 days of life
Necrotizing enterocolitis (NEC)	As diagnosed by NICU team	28 days of life
Hypoxic ischemic encephalopathy	As diagnosed by NICU team	28 days of life
Neonatal pneumonia	As diagnosed by NICU team	28 days of life
Neonatal death	As documented in the EMR	During NICU admission, up to 1 year
Patient satisfaction with exams	Survey regarding their experience with cervical exams	At delivery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: preterm birth; preterm prelabor rupture of membranes; PPROM; speculum exam
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 202301012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No