Banner University Medical Center Tucson
Tucson, Arizona, 85724, United States
NCT Number: NCT03140488
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.
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Female
Interventional
Phase 4
Tucson, Arizona, 85724, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Patients will be randomized to low dose or high dose oxytocin for induction of labor.
Other names: Pitocin, Syntocinon
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.
Time frame: Start of induction to Delivery
rate measured in milliunits/minute during induction of labour, no time limit applied.
Time frame: Start of induction to Delivery
If terbutaline was injected during labor to decrease number or strength of contraction
Time frame: Start of induction to Delivery
total number of patients who undergo cesarean delivery
Time frame: Start of induction to Delivery
Number of patients who undergo cesarean delivery due to labor arrest/ failed induction
Time frame: At delivery
Blood loss in milliliters
Time frame: 5 minutes after birth
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
University of Arizona
Other
High Dose vs. Low Dose Oxytocin for Labor Induction in Obese Women: a Randomized Controlled Trial - the OPS (Obese Pitocin Study) Trial
Acronym: OPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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