ObesityPhase 4OPSNCT03140488
Oxytocin Dosage to Decrease Induction Duration
A Phase 4 study testing Oxytocin in people with Obesity and Labor, Induced, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Labor, Induced, Oxytocin
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 5 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Tucson
Tucson, Arizona, 85724
About this study
Official title: High Dose vs. Low Dose Oxytocin for Labor Induction in Obese Women: a Randomized Controlled Trial - the OPS (Obese Pitocin Study) Trial
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.
Read the detailed description
Obesity is considered a major public health concerns and increases the risk of many comorbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and postpartum. In particular, obese pregnant women have more difficulty going into labor, a longer labor course, and even with pharmacologic treatment, have a higher chance of requiring cesarean delivery.
When pregnant women need help going into labor, they commonly receive a medication called Pitocin on the labor and delivery floor. Pitocin is the brand name and is a synthetic analog to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into labor. This medication has been used widely around the world. There is emerging evidence that obese women need more oxytocin to go into labor compared to their lean cohorts. There are many studies to support the use of different oxytocin dosage protocols (both high and low dose infusion increments). Despite these evidences, a low dose oxytocin regimen is universally used in the United States, regardless of patient characteristics.
This study is a double blinded randomized controlled trial. Both lean and obese cohorts will be recruited for the study. The investigators will randomly place both cohorts into the low or the high dose oxytocin regimen treatment group. The investigators, patients and providers will be blinded and will not know the specific assignments. The purpose of this study is to evaluate the effect of high dose oxytocin in the obese cohort. The hypothesis is that obese patient will have shorter time to delivery with the high dose oxytocin regimen without incurring any additional risks or adverse outcomes.
- Conditions
- Obesity, Labor, Induced, Oxytocin
- Being tested
- Oxytocin
- Keywords
- Induction of labor, Pitocin, BMI
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin, Syntocinon
Patients will be randomized to low dose or high dose oxytocin for induction of labor.
| Study group | Role | What they receive |
|---|---|---|
| Lean-Control | Active comparator | 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. Receives: Drug: Oxytocin |
| Lean-Intervention | Experimental | 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. Receives: Drug: Oxytocin |
| Obese-Control | Active comparator | 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. Receives: Drug: Oxytocin |
| Obese-Intervention | Experimental | 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. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Time to Delivery
Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.
Measured: Start of induction to Delivery
Secondary outcomes (6)
Maximum Oxytocin Infusion Rate
rate measured in milliunits/minute during induction of labour, no time limit applied.
Measured: Start of induction to Delivery
Number of Participants With Terbutaline Use
If terbutaline was injected during labor to decrease number or strength of contraction
Measured: Start of induction to Delivery
Rate of Cesarean Delivery
total number of patients who undergo cesarean delivery
Measured: Start of induction to Delivery
Rate of Cesarean Delivery for Labor Arrest
Number of patients who undergo cesarean delivery due to labor arrest/ failed induction
Measured: Start of induction to Delivery
Maternal Blood Loss
Blood loss in milliliters
Measured: At delivery
Number of Neonates With Apgar Score <7
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
Measured: 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start5 Jun 2017
- Primary completion12 Oct 2018
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 Comparison groups: 1. Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol 2. Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol 3. Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol 4. Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Hill, University of Arizona
- Investigators
- Meghan Hill, MBBS, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140488
- Sponsor's protocol ID
- 1702231223
- Acronym
- OPS
- Status last verified
- Nov 2022
- First submitted
- 19 Apr 2017
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei RM, Bounthavong M, Hill MG. High- vs low-dose oxytocin in lean and obese women: a double-blinded randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100627. doi: 10.1016/j.ajogmf.2022.100627. Epub 2022 Mar 28.
PubMed 35358738
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose vs. Low Dose Oxytocin for Labor Induction in Obese Women: a Randomized Controlled Trial - the OPS (Obese Pitocin Study) Trial
- ClinicalTrials.gov ID
- NCT03140488
- Acronym / sponsor ID
- OPS / 1702231223
- Conditions
- Obesity, Labor, Induced, Oxytocin
- Keywords
- Induction of labor, Pitocin, BMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Posted 20 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is considered a major public health concerns and increases the risk of many comorbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and postpartum. In particular, obese pregnant women have more difficulty going into labor, a longer labor course, and even with pharmacologic treatment, have a higher chance of requiring cesarean delivery.
When pregnant women need help going into labor, they commonly receive a medication called Pitocin on the labor and delivery floor. Pitocin is the brand name and is a synthetic analog to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into labor. This medication has been used widely around the world. There is emerging evidence that obese women need more oxytocin to go into labor compared to their lean cohorts. There are many studies to support the use of different oxytocin dosage protocols (both high and low dose infusion increments). Despite these evidences, a low dose oxytocin regimen is universally used in the United States, regardless of patient characteristics.
This study is a double blinded randomized controlled trial. Both lean and obese cohorts will be recruited for the study. The investigators will randomly place both cohorts into the low or the high dose oxytocin regimen treatment group. The investigators, patients and providers will be blinded and will not know the specific assignments. The purpose of this study is to evaluate the effect of high dose oxytocin in the obese cohort. The hypothesis is that obese patient will have shorter time to delivery with the high dose oxytocin regimen without incurring any additional risks or adverse outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 Comparison groups: 1. Control group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol 2. Intervention group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol 3. Control group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol 4. Intervention group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
| Arm | Type | Receives |
|---|---|---|
| Lean-Control | Active comparator | Drug: Oxytocin1) 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. |
| Lean-Intervention | Experimental | Drug: Oxytocin2) 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. |
| Obese-Control | Active comparator | Drug: Oxytocin3) 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. |
| Obese-Intervention | Experimental | Drug: Oxytocin4) 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| OxytocinAlso: Pitocin, SyntocinonPatients will be randomized to low dose or high dose oxytocin for induction of labor. | Drug | Lean-Control, Lean-Intervention, Obese-Control, Obese-Intervention |
Primary outcome
Length of Time to Delivery
Time frame: Start of induction to Delivery
Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.
6 secondary outcomes
Maximum Oxytocin Infusion Rate
Time frame: Start of induction to Delivery
Number of Participants With Terbutaline Use
Time frame: Start of induction to Delivery
Rate of Cesarean Delivery
Time frame: Start of induction to Delivery
Rate of Cesarean Delivery for Labor Arrest
Time frame: Start of induction to Delivery
Maternal Blood Loss
Time frame: At delivery
Number of Neonates With Apgar Score <7
Time frame: 5 minutes after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35358738Wei RM, Bounthavong M, Hill MG. High- vs low-dose oxytocin in lean and obese women: a double-blinded randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100627. doi: 10.1016/j.ajogmf.2022.100627. Epub 2022 Mar 28.
- 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.
Meghan Hill, MBBS principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin in people with Obesity and Labor, Induced, run by University of Arizona 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 20 Dec 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Time to Delivery (time frame: Start of induction to Delivery). 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 NCT03140488, which also lists 1 linked publication.
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 20 Dec 2022; AzTrials last refreshed its copy on 27 Oct 2026.