RecruitingNot ApplicableNCT07587632

Natural Cervical Ripening to Prevent Pharmacological Induction of Labor - a Pilot Study.


Sponsor

University of Zurich

Enrollment

74 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

As of today, around 25% of all vaginal births happen after induction of labor (IOL). The internal guidelines of the University Hospital Zurich currently recommend pregnant women with a non-insulin dependent gestational diabetes an IOL around term. One possibility to prevent an IOL and increase the chance for a spontaneous onset of birth is a ripening of the cervix by alternative methods in an outpatient setting. The primary objective of this study is to evaluate the effect of natural cervical ripening methods on the time interval between 37 weeks (beginning of the intervention) and the onset of spontaneous labor.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Singleton gestation
  • Non-insulin dependent, dietetically managed gestational diabetes
  • Greater than or equal to 34 weeks.
  • Planned vaginal birth at the University Hospital of Zurich
  • Planned IOL for 40 weeks of gestation.
  • Communication in German and/or English language possible.

Exclusion Criteria9

  • Pregnant women with multiple gestation
  • Fetal macrosomia >95th percentile
  • Intrauterine growth restriction <3rd percentile
  • Already in labor (regular contractions or premature rupture of membranes (PROM)
  • Patients scheduled for IOL before 40 weeks
  • Insulin-dependent diabetes
  • Planned cesarean section
  • Planned birth in an external hospital
  • Inability to follow the procedures e.g. due to language problems, psychological disorders

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREMembrane sweaping and Breast massage

Study intervention: * Membrane sweeping: Circular movements with the finger on the lower uterine segment to separate the lower uterine segment from the membranes during a digital vaginal examination. Twice per week, performed by medical personnel. * Breast massage: Massaging the breast with gentle pressure for a few minutes, followed by a compression towards the nipple using the thumb and index finger in the C position. Repeating this sequence for 60 minutes in total, while alternating the breast every 5 minutes. Performed by the patient herself on 3 days per week (3 times 60 minutes). * Colostrum harvesting: The current standard of care at the Department of Obstetrics of the University Hospital Zurich for pregnant women with a non-insulin-dependent gestational diabetes, beginning at 36 weeks of gestation. Massaging the breast with gentle pressure for a few minutes, followed by a compression towards the nipple using the thumb and index finger in the C position. Repeating this sequence


Locations(1)

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07587632


Related Trials