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Search / Trial NCT03588585

Tension Versus no Tension With Foley Bulb Induction

Launched by HAWAII PACIFIC HEALTH · Jul 13, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods of using a Foley bulb to help prepare the cervix for labor, which is a process called cervical ripening. The trial will compare applying tension to the Foley bulb versus not applying tension at all. This study is being conducted at Kapiolani Medical Center for Women and Children and aims to find out which method works better to assist women who need to be induced for labor.

To participate in this study, women must be at least 18 years old and having their first baby (known as nulliparas) with a single baby positioned head-down. Their pregnancy must also meet specific conditions, such as having an intact amniotic sac and a Bishop score of 6 or lower, which is a way to measure how ready the cervix is for labor. Participants can expect to have the Foley bulb inserted as part of their induction process and will help researchers learn more about the best practices for labor induction.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
  • Cephalic presentation
  • Intact fetal membranes
  • Bishop score less than or equal to 6
  • Age greater than or equal to 18 years
  • Exclusion Criteria:
  • Multiparas
  • Multiple gestation
  • Previous uterine/cervical surgery
  • Ruptured fetal membranes
  • Fetal malpresentation
  • Any contraindication to vaginal delivery at time of admission

About Hawaii Pacific Health

Hawaii Pacific Health is a leading nonprofit healthcare organization dedicated to improving the health and well-being of the communities it serves across Hawaii. With a commitment to innovation and excellence in patient care, Hawaii Pacific Health engages in a wide range of clinical trials aimed at advancing medical research and treatment options. The organization collaborates with healthcare professionals, researchers, and academic institutions to explore new therapies and improve health outcomes, ensuring that patients have access to the latest advancements in medical science. Through its comprehensive approach, Hawaii Pacific Health strives to enhance the quality of care while fostering a culture of research and education within the healthcare community.

Locations

Honolulu, Hawaii, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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