Labor, PrematureCerealNCT03682822
Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial
A study testing Early Artificial rupture of membranes and Delayed Artificial rupture of membranes in people with Labor, Premature, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor, Premature
- What is being tested?
- Early Artificial rupture of membranes and Delayed Artificial rupture of membranes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 24 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm singleton pregnancy between 28.0 and 36.6 completed weeks of gestation
- Fetus in the cephalic position
- Intent to induce labor for vaginal delivery
- If cervical ripening is planned, patient must be enrolled within an hour of initiation of ripening. If no ripening is planned, enrollment must be complete prior to starting induction.
Who cannot join
- Preterm premature rupture of membranes (PPROM)
- Fever or suspected chorioamnionitis prior to start of IOL
- Prior uterine scar
- Infection with HIV/Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) or an active Herpes Simplex Virus (HSV) infection
- Intrauterine fetal demise
- Major fetal anomaly
- Cervical dilation > 4 cm
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center of Houston
Houston, Texas, 77030
About this study
Official title: Comparative Effectiveness of Routine Early Versus Delayed Amniotomy for Pregnancies Less Than 37 Weeks Gestational Age: A Randomized Open Label Trial (CEREAL)
To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.
Read the detailed description
Women presenting with a preterm singleton pregnancy between 28.0 and 36.6 weeks of gestation with cephalic lie and a medical indication for induction of labor will be approached for this study. The patient/provider must be attempting induction with the goal of vaginal delivery. Women with ruptured membranes, suspected intrauterine infection, prior uterine scar, fetal demise, or a fetal anomaly will be excluded. Women that agree to the study will be randomized to 2 groups: the "early amniotomy" group and the "late amniotomy" group.
Women in the early amniotomy group will undergo artificial rupture of membranes (AROM) prior to reaching cervical dilation of 4 cm. Women in the late amniotomy group may not undergo AROM until they reach cervical dilation of greater than 4 cm or they have been on an oxytocin drip for greater than 10 hours with no cervical change. It is possible that a woman in the late amniotomy group will not undergo AROM at all.
The primary outcome under consideration is time in labor. Secondary outcomes include rates of chorioamnionitis, postpartum endometritis, mode of delivery, and neonatal outcomes.
- Conditions
- Labor, Premature
- Being tested
- Early Artificial rupture of membranes, Delayed Artificial rupture of membranes
- Keywords
- Pregnancy, labor induction, preterm
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Artificial rupture of membranesProcedure or surgery
Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible.
Delayed Artificial rupture of membranesProcedure or surgery
Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change.
| Study group | Role | What they receive |
|---|---|---|
| Early artificial rupture of membranes | Experimental | Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible. Receives: Procedure: Early Artificial rupture of membranes |
| Delayed artificial rupture of membranes | Active comparator | Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change. Receives: Procedure: Delayed Artificial rupture of membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration of labor.
The duration of labor begins with administration of the first induction agent (i.e. Cook balloon, Foley catheter, prostaglandins, or oxytocin) and ends with delivery.
Measured: Induction of labor until delivery (1 hr - 48 hrs)
Secondary outcomes (14)
Labor Outcomes:Time from completion of cervical ripening to delivery
When the last induction agent is a foley/Cook balloon, or cervidil (dinoprostone), "completion of cervical ripening" will be defined as the time when the agent is removed. When the last induction agent is misoprostol, "completion of cervical ripening" will be defined as 4 hours after administration of the last dose.
Measured: Induction of labor until delivery (1 hr - 48 hrs)
Labor Outcomes: Delivery before 24 hours from start of Induction of Labor (IOL)
A dichotomization of duration of labor
Measured: Induction of labor until delivery (1 hr - 48 hrs)
Labor Outcomes: Duration of the 2nd stage of labor
Defined as time from the first cervical exam with complete dilation and effacement to the time of delivery
Measured: Induction of labor until delivery (1 hr - 48 hrs)
Maternal Outcome:Cesarean delivery
Mode of delivery
Measured: at delivery
Maternal/Labor Outcomes: Indication for Cesarean delivery
Reason for cesarean delivery
Measured: at delivery
Maternal/Labor Outcomes:Operative vaginal delivery
Use of either a vacuum device or obstetrical forceps
Measured: at delivery
Maternal intrapartum fever or chorioamnionitis
Defined as persistent intrapartum fever and/or suspected or confirmed intraamniotic infection (20)
Measured: during labor to delivery
Post-partum endometritis:
defined as postpartum febrile morbidity in the absence of another causative factor (i.e. wound infection, deep venous thrombosis). Postpartum febrile morbidity is defined as oral temperature ≥ 38.0⁰ C on any 2 of the first 10 days postpartum, exclusive of the first postpartum day
Measured: up to 10 days
Epidural anesthesia
Use of epidural regional anesthesia for pain control during induction of labor
Measured: during labor
Recurrent variable or late decelerations
As defined by The American College of Obstetrics and Gynecology ( ACOG), practice bulletin No 110
Measured: during labor
Meconium stained amniotic fluid
Meconium is noted in the amniotic fluid after rupture of membranes
Measured: during labor and delivery
Tachysystole
As defined by ACOG, practice bulletin No 110
Measured: during labor
Use of amnioinfusion
Placement of an intrauterine catheter and infusion of saline into the uterus during induction of labor
Measured: during labor
Use of intrapartum tocolytics
Administration of a tocolytic drug during labor
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Nov 2018
- Primary completion22 Feb 2020
- Study completion24 Feb 2020
Why it stopped: Covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, PrematureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clifton O'Neill Brock, The University of Texas Health Science Center, Houston
- Investigators
- Clifton O Brock, MD, Principal investigator, University of Texas Health Science Center of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682822
- Sponsor's protocol ID
- HSC-MS-18-0511
- Acronym
- Cereal
- Status last verified
- Apr 2021
- First submitted
- 21 Sep 2018
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Routine Early Versus Delayed Amniotomy for Pregnancies Less Than 37 Weeks Gestational Age: A Randomized Open Label Trial (CEREAL)
- ClinicalTrials.gov ID
- NCT03682822
- Acronym / sponsor ID
- Cereal / HSC-MS-18-0511
- Conditions
- Labor, Premature
- Keywords
- Pregnancy, labor induction, preterm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 22 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 25 Sep 2018 (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.
To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.
Detailed description
Women presenting with a preterm singleton pregnancy between 28.0 and 36.6 weeks of gestation with cephalic lie and a medical indication for induction of labor will be approached for this study. The patient/provider must be attempting induction with the goal of vaginal delivery. Women with ruptured membranes, suspected intrauterine infection, prior uterine scar, fetal demise, or a fetal anomaly will be excluded. Women that agree to the study will be randomized to 2 groups: the "early amniotomy" group and the "late amniotomy" group.
Women in the early amniotomy group will undergo artificial rupture of membranes (AROM) prior to reaching cervical dilation of 4 cm. Women in the late amniotomy group may not undergo AROM until they reach cervical dilation of greater than 4 cm or they have been on an oxytocin drip for greater than 10 hours with no cervical change. It is possible that a woman in the late amniotomy group will not undergo AROM at all.
The primary outcome under consideration is time in labor. Secondary outcomes include rates of chorioamnionitis, postpartum endometritis, mode of delivery, and neonatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early artificial rupture of membranes | Experimental | Procedure: Early Artificial rupture of membranesWomen in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible. |
| Delayed artificial rupture of membranes | Active comparator | Procedure: Delayed Artificial rupture of membranesWomen in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Preterm singleton pregnancy between 28.0 and 36.6 completed weeks of gestation
- Fetus in the cephalic position
- Intent to induce labor for vaginal delivery
- If cervical ripening is planned, patient must be enrolled within an hour of initiation of ripening. If no ripening is planned, enrollment must be complete prior to starting induction.
Key exclusion criteria (7 listed)
- Preterm premature rupture of membranes (PPROM)
- Fever or suspected chorioamnionitis prior to start of IOL
- Prior uterine scar
- Infection with HIV/Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) or an active Herpes Simplex Virus (HSV) infection
- Intrauterine fetal demise
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 |
|---|---|---|
| Early Artificial rupture of membranesWomen in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible. | Procedure or surgery | Early artificial rupture of membranes |
| Delayed Artificial rupture of membranesWomen in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change. | Procedure or surgery | Delayed artificial rupture of membranes |
Primary outcome
Total duration of labor.
Time frame: Induction of labor until delivery (1 hr - 48 hrs)
The duration of labor begins with administration of the first induction agent (i.e. Cook balloon, Foley catheter, prostaglandins, or oxytocin) and ends with delivery.
14 secondary outcomes
Labor Outcomes:Time from completion of cervical ripening to delivery
Time frame: Induction of labor until delivery (1 hr - 48 hrs)
Labor Outcomes: Delivery before 24 hours from start of Induction of Labor (IOL)
Time frame: Induction of labor until delivery (1 hr - 48 hrs)
Labor Outcomes: Duration of the 2nd stage of labor
Time frame: Induction of labor until delivery (1 hr - 48 hrs)
Maternal Outcome:Cesarean delivery
Time frame: at delivery
Maternal/Labor Outcomes: Indication for Cesarean delivery
Time frame: at delivery
Maternal/Labor Outcomes:Operative vaginal delivery
Time frame: at delivery
Maternal intrapartum fever or chorioamnionitis
Time frame: during labor to delivery
Post-partum endometritis:
Time frame: up to 10 days
Epidural anesthesia
Time frame: during labor
Recurrent variable or late decelerations
Time frame: during labor
Meconium stained amniotic fluid
Time frame: during labor and delivery
Tachysystole
Time frame: during labor
Use of amnioinfusion
Time frame: during labor
Use of intrapartum tocolytics
Time frame: during labor
Results and safety
The study was stopped early (reason given: Covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Clifton O Brock, MD principal investigator
University of Texas Health Science Center of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Artificial rupture of membranes and Delayed Artificial rupture of membranes in people with Labor, Premature, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 May 2021. 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?
The study was stopped early (reason given: Covid). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of labor. (time frame: Induction of labor until delivery (1 hr - 48 hrs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2021.