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Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
Nulliparous pregnant women at ≥ 32 weeks' gestation admitted to labor and delivery for IOL and who meet the inclusion and exclusion criteria will be approached by the research staff. Group 1 will be composed of women allocated to the Foley balloon plus misoprostol. These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.
Group 2 will be composed of women allocated to vaginal misoprostol-only. These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Similarly, further management will be left at the discretion of the labor team.
In both groups, if IV oxytocin is indicated, it will be withheld until 4 hours after the last dose of misoprostol to prevent uterine hyperstimulation. Other aspects of labor management will be similar for both groups, including continuous electronic fetal monitoring with external Doppler device or fetal scalp electrode. Uterine contraction assessment will be performed with either an external tocodynamometer or an intrauterine pressure catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined approach: Foley Balloon + Vaginal Misoprostol | Experimental | These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. |
|
| Single approach: Vaginal Misoprostol only | Active Comparator | These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Misoprostol | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Need for Cesarean Delivery | Induction to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Indication for Cesarean Delivery | Categories of Indications for Cesarean Delivery:
| Induction to delivery |
| Induction-to-delivery Interval in Hours |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. | |
| 32299108 | Derived | Viteri OA, Tabsh KK, Alrais MA, Salazar XC, Lopez JM, Fok RY, Chauhan SP, Sibai BM. Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial. Am J Perinatol. 2021 Aug;38(S 01):e123-e128. doi: 10.1055/s-0040-1708805. Epub 2020 Apr 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Approach: Foley Balloon + Vaginal Misoprostol | These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol |
| FG001 | Single Approach: Vaginal Misoprostol Only | These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Approach: Foley Balloon + Vaginal Misoprostol | These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With a Need for Cesarean Delivery | Posted | Count of Participants | Participants | Induction to delivery |
|
From time of induction to time of discharge (about 5 days for mothers, and about 3-8 days for infants)
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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 | Combined Approach: Foley Balloon + Vaginal Misoprostol | These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Foley Balloon + Vaginal Misoprostol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mesk Alrais, MD | The University of Texas Health Science Center at Houston | (713) 566-5735 | Mesk.A.Alrais@uth.tmc.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 | Jul 16, 2018 | Aug 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Foley Balloon + Vaginal Misoprostol |
| Device |
|
| Induction to delivery |
| Number of Participants With a Need for Oxytocin Augmentation | Induction to delivery |
| Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities | Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window. | Induction to delivery |
| Number of Participants With Clinical Chorioamnionitis | Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid. | Induction to delivery |
| Number of Participants With a Need for Operative Vaginal Delivery | Induction to delivery |
| Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Measures of maternal morbidity assessed:
| Induction to discharge (approximately 5 days) |
| Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) | From delivery to neonatal discharge (approximately 2 to 7 days) |
| Number of Newborns With Transient Tachypnea (TTN) | From delivery to neonatal discharge (approximately 2 to 7 days) |
| Number of Newborns With Respiratory Distress Syndrome (RDS) | From delivery to neonatal discharge (approximately 2 to 7 days) |
| Number of Newborns With Meconium Aspiration Syndrome | From delivery to neonatal discharge (approximately 2 to 7 days) |
| Number of Newborns With Culture-proven Sepsis | From delivery to neonatal discharge (approximately 2 to 7 days) |
| Number of Newborns With Seizures | From delivery to neonatal discharge (approximately 2 to 7 days) |
| Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | Measures of neonatal morbidity assessed:
| From delivery to neonatal discharge (approximately 2 to 7 days) |
| BG001 | Single Approach: Vaginal Misoprostol Only | These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Gestational Age | Mean | Standard Deviation | weeks |
|
| Number of participants who are married | Count of Participants | Participants |
|
| Number of participants who had prenatal care | Count of Participants | Participants |
|
| Number of participants with government subsidized insurance | Count of Participants | Participants |
|
| Number of participants with hypertensive disease | Count of Participants | Participants |
|
| Number of participants with diabetes in pregnancy | Count of Participants | Participants |
|
| Body Mass index | Mean | Standard Deviation | kg/m^2 |
|
| Bishop score | Bishop score, also known as cervix score, is a pre-labor scoring system to assist in predicting whether induction of labor will be required. Score ranges from 0 to 13. A score of 5 or less suggests that labor is unlikely to start without induction. A score of 9 or more indicates that labor will most likely commence spontaneously. Scores between 5 and 9 require additional consideration and professional judgement for clinical management. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Single Approach: Vaginal Misoprostol Only | These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol |
|
|
| Secondary | Indication for Cesarean Delivery | Categories of Indications for Cesarean Delivery:
| Only 51 in the Combined arm and 53 in the single arm delivered by cesarean. | Posted | Count of Participants | Participants | Induction to delivery |
|
|
|
| Secondary | Induction-to-delivery Interval in Hours | Posted | Mean | Standard Deviation | hours | Induction to delivery |
|
|
|
| Secondary | Number of Participants With a Need for Oxytocin Augmentation | Posted | Count of Participants | Participants | Induction to delivery |
|
|
|
| Secondary | Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities | Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window. | Posted | Count of Participants | Participants | Induction to delivery |
|
|
|
| Secondary | Number of Participants With Clinical Chorioamnionitis | Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid. | Posted | Count of Participants | Participants | Induction to delivery |
|
|
|
| Secondary | Number of Participants With a Need for Operative Vaginal Delivery | Posted | Count of Participants | Participants | Induction to delivery |
|
|
|
| Secondary | Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Measures of maternal morbidity assessed:
| Posted | Count of Participants | Participants | Induction to discharge (approximately 5 days) |
|
|
|
| Secondary | Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) | Posted | Count of Participants | Participants | From delivery to neonatal discharge (approximately 2 to 7 days) |
|
|
|
| Secondary | Number of Newborns With Transient Tachypnea (TTN) | Posted | Count of Participants | Participants | From delivery to neonatal discharge (approximately 2 to 7 days) |
|
|
|
| Secondary | Number of Newborns With Respiratory Distress Syndrome (RDS) | Posted | Count of Participants | Participants | From delivery to neonatal discharge (approximately 2 to 7 days) |
|
|
|
| Secondary | Number of Newborns With Meconium Aspiration Syndrome | Data was not collected for this outcome measure. | Posted | From delivery to neonatal discharge (approximately 2 to 7 days) |
|
|
| Secondary | Number of Newborns With Culture-proven Sepsis | Posted | Count of Participants | Participants | From delivery to neonatal discharge (approximately 2 to 7 days) |
|
|
|
| Secondary | Number of Newborns With Seizures | Posted | Count of Participants | Participants | From delivery to neonatal discharge (approximately 2 to 7 days) |
|
|
|
| Secondary | Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | Measures of neonatal morbidity assessed:
| Posted | Count of Participants | Participants | From delivery to neonatal discharge (approximately 2 to 7 days) |
|
|
|
| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Single Approach: Vaginal Misoprostol Only | These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Vaginal Misoprostol | 0 | 123 | 0 | 123 | 0 | 123 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Other |
|
| Surgical site infection |
|
| any neonatal injury |
|