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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587632 on ClinicalTrials.gov