MOCA: Digital vs. Speculum Exams for PPROM
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Speculum Exams 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
Same as arm
|
| Active Comparator: Digital Exams 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
Same as arm
|
Outcome Measures
Primary Outcome Measures
- Pregnancy latency [up to 10 weeks]
time from admission to delivery
Secondary Outcome Measures
- Maternal chorioamnionitis [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 [Within 2 weeks of delivery]
Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness
- Maternal sepsis [Within 2 weeks of delivery]
Defined as bacteremia with evidence of organ dysfunction
- Maternal wound infections [Within 2 weeks of delivery]
As diagnosed by the clinicians
- Maternal intensive care unit (ICU) admission [Within 2 weeks of delivery]
transfer to ICU or readmission to ICU
- Maternal death [Within 2 weeks postpartum]
Death of mother
- Composite neonatal morbidity [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 [Up to 1 year]
From delivery until discharge from the NICU
- Need for respiratory support [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 [Within 72 hours of birth]
must be confirmed on blood culture
- Neonatal sepsis at >72 hours of life [28 days of life]
must be confirmed on blood culture
- Neonatal intraventricular hemorrhage (IVH) [28 days of life]
Seen on head ultrasound
- Necrotizing enterocolitis (NEC) [28 days of life]
As diagnosed by NICU team
- Hypoxic ischemic encephalopathy [28 days of life]
As diagnosed by NICU team
- Neonatal pneumonia [28 days of life]
As diagnosed by NICU team
- Neonatal death [During NICU admission, up to 1 year]
As documented in the EMR
- Patient satisfaction with exams [At delivery]
Survey regarding their experience with cervical exams
Eligibility Criteria
Criteria
Inclusion Criteria:
-
24 weeks 0 days gestation to 33 weeks 5 days gestation
-
Clinical or laboratory confirmation of PPROM
-
At least 8 hours and less than 72 hours of clinical stability after rupture event
-
English speaking
Exclusion Criteria:
-
multiple gestations
-
fetal surgery with entry into the amniotic sac this pregnancy
-
contraindications to digital examination
-
COVID-19 positive on admission
-
patients who received greater than one digital exam prior to enrollment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Washington University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Atarjavdan L, Khazaeipour Z, Shahbazi F. Correlation of myometrial thickness and the latency interval of women with preterm premature rupture of the membranes. Arch Gynecol Obstet. 2011 Dec;284(6):1339-43. doi: 10.1007/s00404-011-1841-x. Epub 2011 Feb 5.
- 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.
- 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.
- 202301012