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:

1. Spontaneous rupture of membranes (ROM) ≥1 hour prior to starting induction; ROM defined as clinical history with the presence of 2 of the following 4: pooling, ferning, nitrazine, oligohydramnios. In the absence of clinical history, oligohydramnios AND pooling must be present for ROM to be diagnosed. Oligohydramnios is defined as a total amniotic fluid index of \<5cm or a maximum vertical pocket \<2cm.
2. Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
3. Gestational age ≥ 34 weeks by best obstetric estimate
4. Clinical management decision is vaginal delivery
5. Singleton gestation
6. Cephalic presentation
7. Willing to participate and able to understand and sign the informed consent document before randomization
8. Women of reproductive age

Exclusion Criteria:

1. Multiple gestations
2. Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
3. Latex allergy
4. Greater than 1 prior cesarean delivery
5. Active labor - defined as contractions more frequent than every 5 minutes (or ≥ 12 contractions in 1 hour) associated with ≥ 1 cm cervical change. In the absence of ≥ 1 cm cervical change after 2 hours, patients with contractions can be included in the study.
6. Suspicion of chorioamnionitis
7. Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
8. HIV positive status or AIDS
9. Intrauterine fetal demise
10. Suspected placental abruption, significant hemorrhage
11. Nonreassuring fetal heart rate (FHR) pattern
12. Participation in a competing trial
B: Inclusion Criteria:

* Patients 15 years of age or older.
* Diagnosed to be pregnant with an indication for induction of labor.
* Having a Bishop score of 4 points or less.
* Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of \>28 weeks.
* Willingness to comply with the protocol for the duration of the study.
* Have signed an informed consent.

Exclusion Criteria:

* Any contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation).
* Ruptured membranes.
* Previous cesarean section or any uterine scar.
* Documented labor.
* Suspected fetal distress necessitating immediate intervention.
* Proven malignancy of the cervix.
* Active inflammatory or purulent condition of the lower genital tract.
C: Inclusion Criteria:

* women at \> 24 weeks gestation
* a non-anomalous, singleton fetus in a vertex presentation

Exclusion Criteria:

* history of prior uterine surgery such as cesarean section or myomectomy
* unexplained vaginal bleeding
* latex allergy
* contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
D: 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

Answer: D