Delivery ComplicationNCT06181396
Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
A study testing Oxytocin in people with Delivery Complication and Cesarean Delivery Affecting Fetus, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery Complication, Cesarean Delivery Affecting Fetus
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2023to Oct 2026
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Maternal age ≥ 18 years' old
- Oxytocin administration initiated or renewed during second stage of labor
Who cannot join
- Maternal age < 18 years' old
- Multiple gestation pregnancy
- Known fetal malformations
- Uterine scar
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam medical health campus
Haifa, 31999
Gal Bachar, MD
About this study
Official title: Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes.
Read the detailed description
Cesarean delivery (CD) is one of the most common surgeries performed worldwide. In the last few decades, its rate has steadily increased worldwide, leading to an increase in maternal morbidity and mortality compared to vaginal delivery (VD)1. In 2014, the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal Fetal Medicine (SMFM) published an Obstetric Care Consensus for safe prevention of primary cesarean delivery, allowing an additional hour of pushing during the 2nd stage of labor for both nulliparous and multiparous women before diagnosing prolonged 2nd of labor2-4.
Prolonged 2nd stage is especially common among nulliparous women5, and is defined as more than three hours of pushing6, or four hours for women with a regional anesthesia. Prolonged 2nd stage has been shown to be associated with maternal adverse outcomes, such as assisted-vaginal delivery, CD, and postpartum hemorrhage (PPH)7,8, and neonatal adverse outcomes such as low 5-minute Apgar score, and NICU admissions9.
Oxytocin is the primary and the most widely used pharmacological agent for induction and augmentation of labor10. Administrating oxytocin during labor is a common practice and is used to intensify contractions and decrease the chances of a non-progressive labor and associated adverse outcomes11,12. Despite its extensive use, there are several protocols which varies between different countries and obstetric wards. Likewise, there is no consensus regarding the duration or dosage of oxytocin infusion during labor, and especially during the 2nd stage of labor13.
The study will assess the optimal time initiation of Oxytocin during the 2nd stage of labor, and its association to mode of delivery, and adverse maternal and neonatal outcomes.
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Native oxytocin analog
| Study group | Role | What they receive |
|---|---|---|
| Immediate oxytocin | Experimental | This arm will receive oxytocin when entering 2nd stage (full dilation) Receives: Drug: Oxytocin |
| Delayed oxytocin | Other | This arm will receive oxytocin one hour after entering 2nd stage (full dilation) Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
Vaginal or instrumental or cesarean
Measured: Delivery
Secondary outcomes (8)
2nd stage duration
Minutes
Measured: Delivery
intrapartum fever
Rate of chorioamnionitis
Measured: Delivery or 48 hours postpartum
Meconium stain
Rate
Measured: Delivery
Postpartum hemorrhage
more than 500 ml following vaginal delivery or more than 1000 ml at cesarean delivery
Measured: Delivery
FHR decelerations
Variable or Late Decelerations viewed by the physician according to external fetal monitor.
Measured: Delivery
Neonatal pH
Umbilical cord pH
Measured: Delivery
Neonatal Apgar score
5 minutues Apgar score
Measured: Delivery
Admission of the neonate to neonatal intensive care unit
Admission of the neonate to neonatal intensive care unit
Measured: Immediate postpartum, up to 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Oct 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ComplicationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial of singleton gestations receiving oxytocin during the second stage of labor at a single tertiary medical center. Women will be randomly allocated to one of two groups - immediate initiation of oxytocin at full dilation versus delayed oxytocin initiation following one hour of full dilation.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gal Bachar MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181396
- Sponsor's protocol ID
- 0061-22-RMB
- Status last verified
- Dec 2023
- First submitted
- 10 Sep 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes