Digital vs. Speculum Exams for PPROM

Study Overview
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Brief Summary
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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.

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

Conditions
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PPROM

Intervention / Treatment
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* Procedure: Speculum Exams
* Procedure: Digital Exams


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Speculum Exams<br>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<br>* Same as arm<br>|
| Active Comparator: Digital Exams<br>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<br>* Same as arm<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPROM, speculum exam, preterm birth, preterm prelabor rupture of membranes