Barnes Jewish Hospital
St Louis, Missouri, 63108, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05773014
Digital vs. Speculum Exams for PPROM
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Speculum Exams
ProcedureSame as arm
Digital Exams
ProcedureSame as arm
Primary outcomes
-
Pregnancy latency
Time frame: up to 10 weeks
time from admission to delivery
Secondary outcomes
-
Maternal chorioamnionitis
Time frame: Prior to delivery
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
-
Endomyometritis
Time frame: Within 2 weeks of delivery
Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness
-
Maternal sepsis
Time frame: Within 2 weeks of delivery
Defined as bacteremia with evidence of organ dysfunction
-
Maternal wound infections
Time frame: Within 2 weeks of delivery
As diagnosed by the clinicians
-
Maternal intensive care unit (ICU) admission
Time frame: Within 2 weeks of delivery
transfer to ICU or readmission to ICU
-
Maternal death
Time frame: Within 2 weeks postpartum
Death of mother
-
Composite neonatal morbidity
Time frame: 28 days of life
Need for respiratory support, neonatal sepsis, intraventricular hemorrhage, hypoxic ischemic encephalopathy, necrotizing enterocolitis, pneumonia, or neonatal demise
-
Length of neonatal intensive care unit (NICU) admission
Time frame: Up to 1 year
From delivery until discharge from the NICU
-
Need for respiratory support
Time frame: 28 days of life
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
-
Neonatal sepsis at <72 hours of life
Time frame: Within 72 hours of birth
must be confirmed on blood culture
-
Neonatal sepsis at >72 hours of life
Time frame: 28 days of life
must be confirmed on blood culture
-
Neonatal intraventricular hemorrhage (IVH)
Time frame: 28 days of life
Seen on head ultrasound
-
Necrotizing enterocolitis (NEC)
Time frame: 28 days of life
As diagnosed by NICU team
-
Hypoxic ischemic encephalopathy
Time frame: 28 days of life
As diagnosed by NICU team
-
Neonatal pneumonia
Time frame: 28 days of life
As diagnosed by NICU team
-
Neonatal death
Time frame: During NICU admission, up to 1 year
As documented in the EMR
-
Patient satisfaction with exams
Time frame: At delivery
Survey regarding their experience with cervical exams
Study contacts
Contact information is provided by the study sponsor or research team.
Jaime Strickland
CONTACT
Nandini Raghuraman, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Washington University School of Medicine
Other
Registry information
Official study title
Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
Acronym: MOCA
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 17, 2023
- Registry last updated
- Jan 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Not Yet Recruiting
Antenatal Breastmilk Expression in Pregnant Women at High Risk of Preterm Birth
NCT07191366
Female Urogenital Diseases and Pregnancy Complications, Hypertension, Pregnancy-Induced
View Trial Details
Not Yet Recruiting
Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes
NCT06965049
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Montreal, Quebec, Canada
View Trial Details
Not Yet Recruiting
Preterm Rupture of Membranes Optimising Antibiotics Trial
NCT06906757
Chorioamnionitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
View Trial Details
Not Yet Recruiting
Extended Azithromycin Treatment in Prelabor Rupture of Membranes
NCT07669207
PPROM, Preterm Prelabor Rupture of Membranes
Pittsburgh, Pennsylvania, United States
View Trial Details