Natural cervical ripening to delay pharmacological induction of labor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigator-initiated, single-center randomized controlled trial evaluates natural cervical ripening methods in women with diet-controlled gestational diabetes who are at 37–40 weeks and plan vaginal birth. Participants are assigned to receive membrane sweeping and/or breast massage with potential colostrum–related activities in an outpatient setting to see if spontaneous labor starts sooner. The study aims to measure time from 37 weeks to spontaneous labor, plus rates of spontaneous labor before planned induction, use of oxytocin or induction medications, duration of hospitalization, postpartum hemorrhage, mode of birth, and maternal/neonatal outcomes. Safety and feasibility of these nonpharmacological interventions are also assessed. Enrollment targets 74 eligible pregnant individuals can participate under German or English language instructions at the University Hospital Zurich.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University Hospital Zurich
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Verena Bossung, PD. Dr. med. — University of Zurich
• Study coordinator: Verena Bossung, PD Dr. med.
• Email: verena.bossung@usz.ch
• Phone: +44 43 253 28 47

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.