Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prostaglandin Insert (Propess) Versus Trans-cervical Balloon Catheter for Out-patient Labour Induction: A Randomised Controlled Trial of Feasibility
Brief Summary: This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.


Options:
A: Inclusion Criteria

* Term 37 weeks or more, singleton in cephalic presentation
* Age 18 years and older
* Patient admitted for induction of labor

Exclusion Criteria:

* Malpresentation
* Preterm labor less than 37 weeks of gestation
* Patients with fetal anomalies
* Premature rupture of membranes
* If the cervix is closed and unable to place the foley bulb
* Multiple gestation
* Non-reassuring fetal heart tracing
* Contraindication to misoprostol
* Contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, marginal previa, macrosomia, etc). History of prior uterine surgery such as cesarean section or myomectomy
B: Inclusion Criteria:

Pregnant women with a single fetus and uncomplicated pregnancy, with a gestational age \> 37+ 0 weeks, needing induction of labour

1. ≥18 years of age
2. No medical risk factors.

Exclusion Criteria:

1. Out-patient induction of labour is deemed unsuitable for the following women on the grounds of safety -

   * Grand multiparous women (Parity 5 or more)
   * Multiple pregnancy
   * Women with complex medical or obstetric problems (i.e. placenta previa, recurrent antepartum hemorrhage, diabetes, pre-eclampsia, Intrauterine growth restriction (UGR), Obstetric Cholestasis)
   * Previous caesarean section/uterine scar
2. Women who are contracting and/ or requiring analgesia
3. Women who do not fully understand the information leaflet and unable to provide full informed consent
4. Women for whom out-patient induction is unsuitable according to local hospital protocol
C: Inclusion Criteria:

* Reproductive aged women, pregnant, term gestation (\>37 weeks), undergoing induction of labor, cervical exam acceptable as a candidate for Foley balloon catheter placement (Bishop score \<5), cephalic fetal presentation.

Exclusion Criteria:

* Regular contractions on admission, rupture of membranes, previous uterine scar, low-lying placenta (measured \<3cm to internal os), Bishop score \> 5, contraindication to attempt at vaginal birth, non-English/Spanish speaking, unable to give consent.
D: Inclusion Criteria:

* singleton gestation
* presenting for induction as determined by their primary obstetrical provider
* with fetuses in cephalic presentation
* gestational age greater than 23 weeks

Exclusion Criteria:

* any condition precluding vaginal delivery
* estimated fetal weight \>4500 grams
* a previous attempt at ripening or induction during the pregnancy
* clinically significant cervical or vaginal infection
* chorioamnionitis
* HIV
* hepatitis B or C
* unexplained vaginal bleeding
* low-lying placenta
* abnormal cervical anatomy or cervical cerclage
* latex allergy

Answer: B