Pain Control for Cervical Ripening Balloon
ConditionLabor Induction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
No standard of care exists for pain management during cervical ripening balloon placement. The purpose of this study is to evaluate if vaginal topical lidocaine reduces pain related to cervical ripening balloon placement during induction of labor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Gestational age ≥37 weeks
Viable pregnancy
Intact membranes
Disqualifiers
Allergy or sensitivity to lidocaine
Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural)
Known uterine or cervical anomalies
Trial design
Design model
Parallel
Treatments tested in this trial
topical vaginal application lidocaine gel
DrugApplication of topical vaginal lidocaine prior to cervical balloon ripening
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Topical lidocaineExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient-reported pain during cervical ripening balloon placement.
Patient-reported pain score during cervical ripening balloon placement on a visual analog scale from 0 (no pain) to 10 (most pain).
Time frame
Within 24 hours of cervical balloon ripeningSponsors and contacts
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Source ClinicalTrials.gov