Natural Cervical Ripening to Prevent Pharmacological Induction of Labor - a Pilot Study.
NCT07587632 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2026-05-14
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.
Conditions
- Pregnancy
- Induction of Labor
- Gestational Diabetes Mellitus (GDM)
Interventions
- PROCEDURE
-
Membrane 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
Sponsors & Collaborators
-
University of Zurich
lead OTHER
Principal Investigators
-
Verena Bossung, PD. Dr. med. · University of Zurich
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-10
- Primary Completion
- 2029-03-31
- Completion
- 2029-12-31
Countries
- Switzerland
Study Locations
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