Phase 4
N=1,003
Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
Dystocia
Bottom Line
View on ClinicalTrials.gov: NCT02487797 ↗Enrolled (actual)
1,003
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Number of Participants Delivered by Cesarean — 73; 72 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug); Sodium Chloride 0.9% (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Delivered by Cesarean |
73; 72 | — |
| SECONDARY Labor Augmentation Duration |
9.1; 10.5 | — |
| SECONDARY Number of Participants With Postpartum Hemorrhage |
29; 23 | — |
| SECONDARY Number of Participants With Intrapartum Chorioamnionitis |
52; 78 | — |
| SECONDARY Number of Participants With Postpartum Endometritis |
3; 5 | — |
| SECONDARY Number of Participants Whose Offspring Experiences a Perinatal Death |
0; 0 | — |
| SECONDARY Number of Participants With Umbilical Cord Acidemia |
14; 27 | — |
| SECONDARY Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life |
3; 4 | — |
| SECONDARY Admission to Neonatal Intensive Care Unit |
29; 33 | — |
| SECONDARY Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality |
5; 7 | — |
Summary
Oxytocin is a medication that is often used to strengthen contractions to overcome delayed labor progress. The primary aim of this study is to determine whether receiving a higher dose of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal Apgar score <5 at 5 minutes, and need for neonatal intensive care.
Eligibility Criteria
Inclusion Criteria
- Able to give informed written consent
- Age 18-45 years
- Nulliparous
- Pregnant with a live singleton gestation that is equal to or greater than 36 weeks
- Diagnosed with at least 6 regular uterine contractions in an observation period of no more than 60 minutes and at least one of the following: spontaneous rupture of membranes, OR cervix greater than or equal to 3 centimeters dilated OR cervix at least 80% effaced.
- The participant's attending obstetric physician or midwife has determined that the participant needs administration of oxytocin infusion for labor augmentation. Labor augmentation will be defined as stimulation of uterine contractions when spontaneous contractions have failed to result in progressive cervical dilation of descent of fetus.
Exclusion Criteria
- Women not meeting the above criteria
- History of prior cesarean section or uterine surgery
- Fetus in non-cephalic presentation
- Participant is undergoing labor induction (i.e. cervical ripening)
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT02487797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.