Primary outcomeMean· Start of induction to Delivery
Length of Time to Delivery
| Group | Value (minutes) | Spread |
|---|---|---|
| Lean-Control | 796 | 411 |
| Lean-Intervention | 694 | 466 |
| Obese-Control | 715 | 497 |
| Obese-Intervention | 762 | 594 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataOxytocin Dosage to Decrease Induction Duration
Short name OPS
NCTNCT03140488 (opens ClinicalTrials.gov in a new tab)Other id1702231223
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 140 participants (actual)
- Sponsor
- University of Arizona · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 5 Jun 2017
- Primary completion
- 12 Oct 2018
- Completion
- 5 Sept 2019
- First posted
- 4 May 2017
- Last update posted
- 20 Dec 2022
- Conditions
- Obesity · Labor, Induced · Oxytocin
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2017201820192020
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a randomized controlled trial in which women are allocated either 'high dose' or 'low dose' oxytocin infusions for induction of labour. The randomization is stratified by maternal body mass index.
Interventions
- OxytocinDrug
Arms4
Active comparator
Lean-Control
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Experimental
Lean-Intervention
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Active comparator
Obese-Control
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Experimental
Obese-Intervention
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Primary outcomes1
Outcomes the sponsor listed as primary.
Length of Time to Delivery
Time frame · Start of induction to Delivery
Registry description
Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.
Secondary outcomes(6)
Maximum Oxytocin Infusion Rate
Time frame · Start of induction to Delivery
Registry description
rate measured in milliunits/minute during induction of labour, no time limit applied.
Number of Participants With Terbutaline Use
Time frame · Start of induction to Delivery
Registry description
If terbutaline was injected during labor to decrease number or strength of contraction
Rate of Cesarean Delivery
Time frame · Start of induction to Delivery
Registry description
total number of patients who undergo cesarean delivery
Rate of Cesarean Delivery for Labor Arrest
Time frame · Start of induction to Delivery
Registry description
Number of patients who undergo cesarean delivery due to labor arrest/ failed induction
Maternal Blood Loss
Time frame · At delivery
Registry description
Blood loss in milliliters
Number of Neonates With Apgar Score <7
Time frame · 5 minutes after birth
Registry description
5 minute Apgar Score \<7 \*Apgar is an acronym for which each criterion is given a minimum of 0 and maximum of 2 points: Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), Respiration
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· Start of induction to Delivery
Maximum Oxytocin Infusion Rate
| Group | Value (milliunits per minute) | Spread |
|---|---|---|
| Lean-Control | 14.85 | 7.16 |
| Lean-Intervention | 33.00 | 25.64 |
| Obese-Control | 17.14 | 10.99 |
| Obese-Intervention | 39.60 | 21.09 |
Secondary outcomeCount of participants· Start of induction to Delivery
Number of Participants With Terbutaline Use
| Group | Value (Participants) |
|---|---|
| Lean-Control | 0 |
| Lean-Intervention | 0 |
| Obese-Control | 0 |
| Obese-Intervention | 1 |
Secondary outcomeCount of participants· Start of induction to Delivery
Rate of Cesarean Delivery
| Group | Value (Participants) |
|---|---|
| Lean-Control | 5 |
| Lean-Intervention | 2 |
| Obese-Control | 4 |
| Obese-Intervention | 1 |
Secondary outcomeCount of participants· Start of induction to Delivery
Rate of Cesarean Delivery for Labor Arrest
| Group | Value (Participants) |
|---|---|
| Lean-Control | 1 |
| Lean-Intervention | 1 |
| Obese-Control | 3 |
| Obese-Intervention | 0 |
Secondary outcomeMean· At delivery
Maternal Blood Loss
| Group | Value (milliliters) | Spread |
|---|---|---|
| Lean-Control | 391.14 | 207.96 |
| Lean-Intervention | 358.57 | 166.49 |
| Obese-Control | 404.29 | 226.99 |
| Obese-Intervention | 491.43 | 342.89 |
Secondary outcomeCount of participants· 5 minutes after birth
Number of Neonates With Apgar Score <7
| Group | Value (Participants) |
|---|---|
| Lean-Control | 0 |
| Lean-Intervention | 3 |
| Obese-Control | 0 |
| Obese-Intervention | 1 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Lean-Control1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage. Time frame measured from start of oxytocin infusion until the mother is discharged from hospital after giving birth. | 0 / 35 | 0 / 35 | 0 / 35 |
| Lean-Intervention2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage. Time frame measured from start of oxytocin infusion until the mother is discharged from hospital after giving birth. | 0 / 35 | 0 / 35 | 0 / 35 |
| Obese-Control3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage. Time frame measured from start of oxytocin infusion until the mother is discharged from hospital after giving birth. | 0 / 35 | 0 / 35 | 0 / 35 |
| Obese-Intervention4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage. Time frame measured from start of oxytocin infusion until the mother is discharged from hospital after giving birth. | 0 / 35 | 0 / 35 | 0 / 35 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2022
High- vs low-dose oxytocin in lean and obese women: a double-blinded randomized controlled trial.
Wei et al. 2022American journal of obstetrics & gynecology MFMcited by 4
PMID 35358738DOI 10.1016/j.ajogmf.2022.100627PUB-35358738
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Singleton pregnancy ≥ 37 weeks gestation
* Patient presented for induction of labor who is determined to be a candidate for oxytocin
* Cephalic presentation
* Reassuring fetal health assessment (no abnormal findings in fetal assessment, see below)
* Meeting one of the following BMI category:
Obese group: BMI ≥30 at \<20 weeks of pregnancy, or BMI ≥35 at a term gestation of pregnancy Lean group: BMI ≤25 at \<20 weeks of pregnancy, or BMI ≤28 at a term gestation of pregnancy
Exclusion Criteria:
* Non-reassuring fetal assessment at the time of recruitment
* Previous cervical ripening agents (cytotec, cervidil, cervical Foley Balloon)
* \<18 years of age
* Prisoners
* Any patients contraindicated for vaginal delivery
* Multiple gestations
* History of previous cesarean delivery
* Patients with history of significant cardiac disease
* Fetal demise
* Estimated fetal weight greater than 4500 grams in diabetic and 5000 grams in non-diabetic mother
* Ruptured membranes
* Spontaneous labor (latent or active phase)
* Augmentation of labor (latent or active phase)
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