Digital vs. Speculum Exams for PPROM

PPROM Clinical Trial

— MOCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773014
• Other study ID #: 202301012
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Julia Burd, MD
• Phone: (314) 362-7135
• Email: burd.j[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: January 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• PPROM

Intervention

Procedure:
• Speculum Exams
Same as arm
• Digital Exams
Same as arm

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy latency	time from admission to delivery	up to 10 weeks
Secondary	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
Secondary	Endomyometritis	Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness	Within 2 weeks of delivery
Secondary	Maternal sepsis	Defined as bacteremia with evidence of organ dysfunction	Within 2 weeks of delivery
Secondary	Maternal wound infections	As diagnosed by the clinicians	Within 2 weeks of delivery
Secondary	Maternal intensive care unit (ICU) admission	transfer to ICU or readmission to ICU	Within 2 weeks of delivery
Secondary	Maternal death	Death of mother	Within 2 weeks postpartum
Secondary	Composite neonatal morbidity	Need for respiratory support, neonatal sepsis, intraventricular hemorrhage, hypoxic ischemic encephalopathy, necrotizing enterocolitis, pneumonia, or neonatal demise	28 days of life
Secondary	Length of neonatal intensive care unit (NICU) admission	From delivery until discharge from the NICU	Up to 1 year
Secondary	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
Secondary	Neonatal sepsis at <72 hours of life	must be confirmed on blood culture	Within 72 hours of birth
Secondary	Neonatal sepsis at >72 hours of life	must be confirmed on blood culture	28 days of life
Secondary	Neonatal intraventricular hemorrhage (IVH)	Seen on head ultrasound	28 days of life
Secondary	Necrotizing enterocolitis (NEC)	As diagnosed by NICU team	28 days of life
Secondary	Hypoxic ischemic encephalopathy	As diagnosed by NICU team	28 days of life
Secondary	Neonatal pneumonia	As diagnosed by NICU team	28 days of life
Secondary	Neonatal death	As documented in the EMR	During NICU admission, up to 1 year
Secondary	Patient satisfaction with exams	Survey regarding their experience with cervical exams	At delivery