The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.

Phase 1

• Conditions: ormal risk nulliparous women who have no pregnancy-related or medical contraindication to Induction of Labour; MedDRA version: 20.0Level: LLTClassification code 10055563Term: Labor inductionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2019-004697-25-IE
• Lead Sponsor: The Rotunda Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-20
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 327

Inclusion Criteria

•Normal risk nulliparous women (as defined in trial objectives)
•Age =18 and <40 years
•Singleton pregnancy
•No contraindications to induction of labour
•Must agree to outpatient induction at 39 weeks
•No relevant medical issues in or outside of pregnancy. This is assessed by a doctor on a case by case basis. Relevant medical issues would be inclusive of the systems disorders as in exclusion criteria. Non relevant medical issues may include, but are not limited to: anxiety/depression not requiring medications, history of urinary tract infections, past history of sexually transmitted infections that have been successfully treated, history of abnormal cervical smear tests, incidence of human papillomavirus, varicose veins, minor surgery or any surgery that would not result in contraindication to induction of labour)
•Must live within 30 minutes or 15km of hospital and have transport to hospital at all times during induction period
•A normal amniotic fluid index (AFI) at 39 weeks’ gestation is between 8 cm and 20 cm
•Biophysical Profile Score (BPS) is 8/8
•Bishops score <6 at Visit 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 327
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Multiparous women
•Women with uterine scar
•Women with low lying placenta
•Women with BMI > 35kg/m2
•Multiple gestation
•Known fetal anomaly or fetal growth restriction or oligohydramnios
•Known maternal health problem e.g. Hypertensive disease, cardiac disease, renal disease, diabetes, pulmonary disease, hepatic disease which would directly affect the risk status of the woman. This is assessed clinically on a case by case basis.
•Women with no transport to hospital or women who live >30 mins or >15km from the hospital
•Patients who have difficulty understanding the required protocol and follow up instructions (e.g. language barriers)
•Women <39+0 or greater than 39+4 weeks’ gestation at the time of induction of labour (Visit 2)
-Gestational age will be based on initial dating scan between 7-14 weeks, which confirms gestational age by CRL.
•Any factor which is a contraindication to induction of labour
•Contraindications to trial treatment include patients that fall into any of the following categories:

oIf labour has started.
oIf oxytocic drugs and/or other labour induction agents have been given.
oWhen strong prolonged uterine contractions would be inappropriate
oPatients who have had previous major uterine surgery, e.g. Caesarean section, myomectomy
oPatients with a clinical suspicion for cephalopelvic disproportion
oPatients with fetal malpresentation
oPatients with suspicion or evidence of non-reassuring fetal testing
oWho have had previous major surgery (e.g. Other than biopsies and cervical abrasion) or rupture of the uterine cervix
oWhen there is current pelvic inflammatory disease, unless adequate prior treatment has been instituted.
oPatients with hypersensitivity to dinoprostone or to any of the excipients listed in the SmPC for Propess/Prostin
oPatients with placenta previa or unexplained vaginal bleeding during the current pregnancy.
oPatients with evidence or any sign of infection, including genital tract infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified