PPROMMOCANCT05773014
Digital vs. Speculum Exams for PPROM
A study testing Speculum Exams and Digital Exams in people with PPROM, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- PPROM
- What is being tested?
- Speculum Exams and Digital Exams
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications to digital examination
- COVID-19 positive on admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63108
Nandini Raghuraman, MD, nraghuraman@wustl.edu
About this study
Official title: Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
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.
- Conditions
- PPROM
- Being tested
- Speculum Exams, Digital Exams
- Keywords
- PPROM, speculum exam, preterm birth, preterm prelabor rupture of membranes
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speculum ExamsProcedure or surgery
Same as arm
Digital ExamsProcedure or surgery
Same as arm
| Study group | Role | What they receive |
|---|---|---|
| Speculum Exams | Active comparator | 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. Receives: Procedure: Speculum Exams |
| Digital Exams | Active comparator | 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. Receives: Procedure: Digital Exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy latency
time from admission to delivery
Measured: up to 10 weeks
Secondary outcomes (17)
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
Measured: Prior to delivery
Endomyometritis
Clinical diagnosis of uterine infection after delivery, typically with fever and fundal tenderness
Measured: Within 2 weeks of delivery
Maternal sepsis
Defined as bacteremia with evidence of organ dysfunction
Measured: Within 2 weeks of delivery
Maternal wound infections
As diagnosed by the clinicians
Measured: Within 2 weeks of delivery
Maternal intensive care unit (ICU) admission
transfer to ICU or readmission to ICU
Measured: Within 2 weeks of delivery
Maternal death
Death of mother
Measured: Within 2 weeks postpartum
Composite neonatal morbidity
Need for respiratory support, neonatal sepsis, intraventricular hemorrhage, hypoxic ischemic encephalopathy, necrotizing enterocolitis, pneumonia, or neonatal demise
Measured: 28 days of life
Length of neonatal intensive care unit (NICU) admission
From delivery until discharge from the NICU
Measured: 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
Measured: 28 days of life
Neonatal sepsis at <72 hours of life
must be confirmed on blood culture
Measured: Within 72 hours of birth
Neonatal sepsis at >72 hours of life
must be confirmed on blood culture
Measured: 28 days of life
Neonatal intraventricular hemorrhage (IVH)
Seen on head ultrasound
Measured: 28 days of life
Necrotizing enterocolitis (NEC)
As diagnosed by NICU team
Measured: 28 days of life
Hypoxic ischemic encephalopathy
As diagnosed by NICU team
Measured: 28 days of life
Neonatal pneumonia
As diagnosed by NICU team
Measured: 28 days of life
Neonatal death
As documented in the EMR
Measured: During NICU admission, up to 1 year
Patient satisfaction with exams
Survey regarding their experience with cervical exams
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start27 Mar 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PPROMStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773014
- Sponsor's protocol ID
- 202301012
- Acronym
- MOCA
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 8113640Alexander 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.
PubMed 11035354Lewis 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.
PubMed 1407885Singhal, 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05773014
- Acronym / sponsor ID
- MOCA / 202301012
- Conditions
- PPROM
- Keywords
- PPROM, speculum exam, preterm birth, preterm prelabor rupture of membranes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speculum Exams | Active comparator | Procedure: Speculum ExamsIf 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. |
| Digital Exams | Active comparator | Procedure: Digital ExamsIf 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications to digital examination
- COVID-19 positive on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speculum ExamsSame as arm | Procedure or surgery | Speculum Exams |
| Digital ExamsSame as arm | Procedure or surgery | Digital Exams |
Primary outcome
Pregnancy latency
Time frame: up to 10 weeks
time from admission to delivery
17 secondary outcomes
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
Necrotizing enterocolitis (NEC)
Time frame: 28 days of life
Hypoxic ischemic encephalopathy
Time frame: 28 days of life
Neonatal pneumonia
Time frame: 28 days of life
Neonatal death
Time frame: During NICU admission, up to 1 year
Patient satisfaction with exams
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 8113640Sukcharoen 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.
- Background: PubMed 11035354Alexander 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.
- Background: PubMed 1407885Lewis 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.
- BackgroundSinghal, 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speculum Exams and Digital Exams in people with PPROM, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nandini Raghuraman, MD (3142732939, nraghuraman@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy latency (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773014, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.