Clinical trial NCT05773014: Digital vs. Speculum Exams for PPROM
Official title: Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PPROM
Keywords: PPROM
speculum exam
preterm birth
preterm prelabor rupture of membranes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Pregnancy latency
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Maternal chorioamnionitis
timeFrame: Prior to delivery
measure: Endomyometritis
timeFrame: Within 2 weeks of delivery
measure: Maternal sepsis
timeFrame: Within 2 weeks of delivery
measure: Maternal wound infections
timeFrame: Within 2 weeks of delivery
measure: Maternal intensive care unit (ICU) admission
timeFrame: Within 2 weeks of delivery
measure: Maternal death
timeFrame: Within 2 weeks postpartum
measure: Composite neonatal morbidity
timeFrame: 28 days of life
measure: Length of neonatal intensive care unit (NICU) admission
timeFrame: Up to 1 year
measure: Need for respiratory support
timeFrame: 28 days of life
measure: Neonatal sepsis at <72 hours of life
timeFrame: Within 72 hours of birth
measure: Neonatal sepsis at >72 hours of life
timeFrame: 28 days of life
measure: Neonatal intraventricular hemorrhage (IVH)
timeFrame: 28 days of life
measure: Necrotizing enterocolitis (NEC)
timeFrame: 28 days of life
measure: Hypoxic ischemic encephalopathy
timeFrame: 28 days of life
measure: Neonatal pneumonia
timeFrame: 28 days of life
measure: Neonatal death
timeFrame: During NICU admission, up to 1 year
measure: Patient satisfaction with exams
timeFrame: At delivery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
References:
citation: 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.
citation: 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.
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.
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.