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Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.
Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early amniotomy | Experimental | Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. |
|
| Delayed amniotomy | Active Comparator | Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotomy | Procedure | Artificial rupture of amniotic membranes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Active Phase of Labor | Total time from initiation of labor induction to reaching 6 cm cervical dilation | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Delivery | Total time from initiation of labor induction to delivery | At delivery |
| Vaginal Delivery Rate | Rate of vaginal delivery within 24, 36, and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marissa Berry, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77550 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38367749 | Derived | Berry M, Lamiman K, Slan MN, Zhang X, Arena Goncharov DD, Hwang YP, Rogers JA, Pacheco LD, Saade GR, Saad AF. Early vs delayed amniotomy following transcervical Foley balloon in the induction of labor: a randomized clinical trial. Am J Obstet Gynecol. 2024 May;230(5):567.e1-567.e11. doi: 10.1016/j.ajog.2024.01.028. Epub 2024 Feb 15. |
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150 subjects were enrolled between October 2020 and March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Amniotomy | Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. |
| FG001 | Delayed Amniotomy | Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No participants were excluded after enrollment but prior to assignment to groups. However, one participant was excluded after group assignment but prior to the intervention due to the development of a contraindication to the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Amniotomy | Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Active Phase of Labor | Total time from initiation of labor induction to reaching 6 cm cervical dilation | Posted | Median | Full Range | minutes | At delivery |
|
Until the time of discharge from the hospital, an average of 3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Amniotomy | Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marissa Berry | University of Texas Medical Branch | 402-772-4099 | majberry@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2022 | Jun 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000074885 | Amniotomy |
| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Foley balloon | Device | The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. |
|
|
| At delivery |
| Cesarean Section Rate | Rate of cesarean section and indications | At delivery |
| Maternal Infection Composite | Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection | From admission to discharge, up to 2 weeks |
| Umbilical Cord Prolapse | Rates of umbilical cord prolapse | At delivery |
| Neonatal Outcome Composite | Neonatal outcome composite including NICU admission, respiratory support, hypoxic ischemic encephalopathy, seizures, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, hypotension requiring pressors, and perinatal death. | From admission to discharge, up to 2 weeks |
| BG001 |
| Delayed Amniotomy |
Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Time to Delivery | Total time from initiation of labor induction to delivery | Not Posted | At delivery | Participants |
| Secondary | Vaginal Delivery Rate | Rate of vaginal delivery within 24, 36, and 48 hours | Not Posted | At delivery | Participants |
| Secondary | Cesarean Section Rate | Rate of cesarean section and indications | Not Posted | At delivery | Participants |
| Secondary | Maternal Infection Composite | Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection | Not Posted | From admission to discharge, up to 2 weeks | Participants |
| Secondary | Umbilical Cord Prolapse | Rates of umbilical cord prolapse | Not Posted | At delivery | Participants |
| Secondary | Neonatal Outcome Composite | Neonatal outcome composite including NICU admission, respiratory support, hypoxic ischemic encephalopathy, seizures, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, hypotension requiring pressors, and perinatal death. | Not Posted | From admission to discharge, up to 2 weeks | Participants |
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Delayed Amniotomy | Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. | 0 | 74 | 0 | 74 | 0 | 74 |
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