Natural Cervical Ripening to Prevent Pharmacological Induction of Labor - a Pilot Study.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Zurich
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Membrane sweaping and Breast massage
Procedure/SurgeryStudy 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
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Study InterventionExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
the time interval between 37/0 weeks of gestation and the onset of labor.
Time frame
Between 37/0 weeks of gestation until the onset of laborSponsors and contacts
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Source ClinicalTrials.gov