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Pregnant Patients With ObesityPhase 4HILIO-PILOTNCT05289869

A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity

A Phase 4 study testing High-dose oxytocin and Low-dose oxytocin in people with Pregnant Patients With Obesity, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight. The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Pregnant Patients With Obesity
What is being tested?
High-dose oxytocin and Low-dose oxytocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
6 Apr 2022to 28 Oct 2022
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Nulliparity
  • Maternal age >18 years
  • Gestational age ≥37w0d
  • Induction of labor, defined as initiation of labor with medication or intracervical Foley catheter in a patient without observed spontaneous cervical change and <6 contractions per hour (average of one contraction every 10 minutes) at the time of initial presentation. Women with prelabor rupture of membranes (PROM) can be included if the other criteria are also met with regards to cervical dilation and contractions.
  • Singleton gestation
  • Cephalic presentation
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  • Indication for oxytocin use in the first stage of labor
  • No contraindication to labor or vaginal delivery
  • Pre-pregnancy BMI ≥30 kg/m2 based on patient report and confirmed by pre-pregnancy or first trimester weight as recorded in the medical record
  • Cervical dilation ≤4 cm at time of initiation of induction

Who cannot join

  • Fetal demise
  • Major fetal congenital malformation or known chromosomal abnormality
  • Prior uterine surgery (e.g., cesarean, myomectomy)
  • Non-reassuring fetal wellbeing as indication for induction
  • Intraamniotic infection suspected or diagnosed prior to randomization
  • Non-English
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  • Multifetal gestation
  • Gestational age <37 weeks
  • Spontaneous labor
  • Cervical dilation > 4 cm at initiation of induction
  • Initiation of oxytocin in the second stage of labor
  • Use of oxytocin prior to randomization or planned use of oxytocin with foley catheter for cervical ripening
  • Fetal malpresentation
  • Estimated fetal weight >4500 g in a patient with diabetes, or estimated fetal weight >5000 g in a non-diabetic patient
  • Abnormal placentation (e.g. previa, suspected placenta accreta spectrum)
  • Physician/provider or patient refusal

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: The HILIO Trial: High vs. Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity- PILOT STUDY

Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight. The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood. Oxytocin is the mostly common medication used in induction of labor, yet optimal dosing of this medication is unknown. Studies have suggested that patients with obesity may be less responsive to oxytocin. This trial will compare a high and low dose oxytocin dosing regimen for the induction of labor in women with obesity.

Read the detailed description

This study is a pragmatic single center randomized, double blinded controlled trial. Nulliparous women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 undergoing induction of labor at ≥37 weeks' gestation will be eligible for enrollment. Women will be randomly allocated to receive oxytocin using either a high-dose or low-dose regimen. Patients, providers, and research staff will be blinded to the dosing regimen. All other aspects of obstetric management will be at the discretion of the patient's clinical care team.

Postpartum maternal, neonatal, and delivery outcomes will be collected. Postpartum data through hospital discharge will be collected from the medical record. Information about complications following hospital discharge through 6 weeks after delivery will be collected during a research follow-up telephone call performed 6-8 weeks following delivery.

Being tested
High-dose oxytocin, Low-dose oxytocin
Keywords
Oxytocin, Pregnant patients with obesity, Induction of labor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-dose oxytocinDrug

    Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

  • Low-dose oxytocinDrug

    Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.

Study groups in NCT05289869
Study groupRoleWhat they receive
High-dose oxytocin regimenExperimentalStarting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.
Receives: Drug: High-dose oxytocin
Low-dose oxytocin regimenExperimentalStarting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.
Receives: Drug: Low-dose oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Delivered by Cesarean

    Measured: Until delivery

Secondary outcomes (16)

  1. Duration of Time From Start of Induction to Delivery

    Time from start of induction with medication or Foley catheter until delivery

    Measured: From start of induction to delivery

  2. Duration of the First Stage of Labor

    Time from start of labor to complete dilation

    Measured: From start of induction to delivery

  3. Occurrence of Tachysystole

    Defined as more than 5 contractions in 10 minutes averaged over 30 minutes

    Measured: From start of induction to delivery

  4. Incidence of Uterine Rupture

    Defined as a complete disruption of all uterine layers including serosa

    Measured: From start of induction to delivery

  5. Incidence of Clinical Chorioamnionitis

    Defined based on clinical diagnosis as documented by the clinical care team

    Measured: From start of induction thorough delivery

  6. Incidence of Postpartum Maternal Infectious Morbidity

    Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record

    Measured: Within 6 weeks following delivery

  7. Incidence of Maternal Death

    Measured: Within 6 weeks of delivery

  8. Incidence of Immediate Postpartum Hemorrhage

    Defined as >1000 mL of blood loss within 24 hours of delivery

    Measured: Within 24 hours of delivery

  9. Incidence of Maternal Blood Transfusion

    Defined as need for blood transfusion

    Measured: From randomization through hospital discharge up to 6 weeks portpartum

  10. Incidence of Maternal ICU Admission

    Measured: From randomization through 6 weeks postpartum

  11. Incidence of Composite Neonatal Morbidity Outcomes

    Apgar score <5 at 5 min, arterial cord pH <7.0 or base deficit >12 mmol/dL, perinatal death

    Measured: Within 6 weeks of delivery

  12. Incidence of NICU Admission

    Measured: Within 6 weeks of delivery

  13. Maternal Length of Stay

    Duration of hospitalization for delivery

    Measured: Within 6 weeks of delivery

  14. Neonatal Length of Stay

    Duration of birth hospitalization

    Measured: Within 6 weeks of delivery

  15. Perception of the Labor, Birth, and Postpartum Experience

    Patient perception as measured using the validated Childbirth Perception Scale. This is a 12-item instrument developed to assess a patient's perception of the labor and delivery experience. Each item is formatted on a four-point scale ranging from 0 to 3. The overall range in total score is 1-36 with higher scores indicating a less positive perception.

    Measured: Assessed within 12-96 hours after delivery

  16. Labor Agentry Score

    Patient perception of labor agentry as measured using validated Labor Agentry Scale. This 29-item tool was developed to assess a patient's expectancies and experiences with control in labor. Each item is scored 1 to 7. Overall total score can range from 29-201 with higher scores indicated greater perceived control during childbirth.

    Measured: Assessed within 12-96 hours after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start6 Apr 2022
  3. Primary completion18 Sep 2022
  4. Study completion28 Oct 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05289869
Sponsor's protocol ID
2021H0432
Acronym
HILIO-PILOT
Status last verified
Nov 2023
First submitted
25 Feb 2022
Last updated
29 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing High-dose oxytocin and Low-dose oxytocin in people with Pregnant Patients With Obesity, run by Ohio State University 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 10 inclusion and 16 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 29 Nov 2023. 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 6 Mar 2023). 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?

Number of Participants Delivered by Cesarean (time frame: Until 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 NCT05289869.

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 29 Nov 2023.

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