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Completed

NCT Number: NCT01962831

Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter

The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.

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Key information

Conditions

Obesity Body Weight Labor, Induced Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regina Qu'Appelle Health Region

Regina, Saskatchewan, S4P0W5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese (BMI >30 before 20 weeks gestational age)
  • Singleton pregnancy
  • Vertex presentation
  • Bishop Score <6
  • Intact membranes
  • Gestational age 37+0 to 42+0
  • Normal fetal heart tracing on admission for ripening

Exclusion criteria

  • Induction of labour for intrauterine fetal demise
  • Intrauterine growth restriction
  • Suspected abruption at the start of induction
  • Any contraindication for a vaginal delivery

Treatment and study plan

Dinoprostone

Drug

Other names: Cervidil

Single balloon foley catheter

Device

Primary outcomes

  1. Time(hours) from initiation of induction of labour to vaginal delivery

    Time frame: Will be assessed at the end of each vaginal delivery

Secondary outcomes

  1. Number of vaginal deliveries within 24 hours in each group

    Time frame: 2 years

  2. Number of cesarean sections in each group

    Time frame: 2 years

  3. Number of operative vaginal deliveries in each group

    Time frame: 2 years

  4. Number of chorioamnionitis cases in each group

    Time frame: 2 years

  5. Number of patients that required oxytocin administration in each group

    Time frame: 2 years

  6. Number of patients that required an epidural in each group

    Time frame: 2 years

  7. Number of babies that required neonatal intensive care unit (NICU) admission in each group

    Time frame: 2 years

  8. Number of babies that had an arterial pH <7 in each group

    Time frame: 2 years

  9. Number of babies that had an APGAR score <7 at 5 minutes

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Saskatchewan Health Authority - Regina Area

Other

Registry information

Official study title

Randomized Controlled Trial: Single Balloon Catheter Versus Dinoprostone Vaginal Insert for Induction of Labour of Women With a BMI Equal to or Greater Than 30

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2013
Registry last updated
Oct 13, 2016

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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