Digital vs. Speculum Exams for PPROM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Speculum Exams, Digital Exams.
- Who it may be relevant to
- Registry conditions: PPROM. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Speculum Exams
Same as arm - Procedure Digital Exams
Same as arm
Primary outcome measures
- Pregnancy latency [Time frame: up to 10 weeks]
Secondary outcome measures (12)
- Maternal chorioamnionitis [Time frame: Prior to delivery]
- Endomyometritis [Time frame: Within 2 weeks of delivery]
- Maternal sepsis [Time frame: Within 2 weeks of delivery]
- Maternal wound infections [Time frame: Within 2 weeks of delivery]
- Maternal intensive care unit (ICU) admission [Time frame: Within 2 weeks of delivery]
- Maternal death [Time frame: Within 2 weeks postpartum]
- Composite neonatal morbidity [Time frame: 28 days of life]
- Length of neonatal intensive care unit (NICU) admission [Time frame: Up to 1 year]
- Need for respiratory support [Time frame: 28 days of life]
- Neonatal sepsis at <72 hours of life [Time frame: Within 72 hours of birth]
- Neonatal sepsis at >72 hours of life [Time frame: 28 days of life]
- Neonatal intraventricular hemorrhage (IVH) [Time frame: 28 days of life]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Barnes Jewish Hospital — St Louis
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. PMID 8113640
- 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
- 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
- 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.
Identifiers
NCT: NCT05773014 · 202301012