Cervix; Insufficient Dilatation in Labor Clinical Trial
Official title:
Comparison Between the Use of Standard Oxytocin Induction Protocol and the Double-balloon Catheter Device With Concurrent Oxytocin
The paucity of published data concerning the issue of mechanical labor induction in the setting of Term PROM has led us to undertake the present clinical trial. This study is designed to compare the efficacy and safety of the standard Oxytocin induction protocol with the double-balloon catheter device with concurrent oxytocin administration in patients with Term PROM and unfavorable cervical conditions.
This will be a prospective randomised trial. Two hundred pregnant women with term PROM and
an unfavourable cervix (Bishop Score ≤ 4) are expected to be entered into the study (see
statistical analysis below).
All eligible women will be presented with the study protocol by a study coordinator. Women
interested in participating will read and sign the informed consent. Subsequently, the
following screening medical procedures will be completed: medical and gynecological history,
physical and vaginal examination, ultrasonography to: (i) Confirm fetal vertex presentation,
(ii) Exclude placenta previa and (iii) Assess cervical length and posterior cervical angle.
(iv) Asses bio-physical profile score
A non-stress test will be performed in order to monitor:
1. The fetal heart pattern for the presence or absence of decelerations and
2. The presence of uterine contractions. All women will undergo a pelvic examination by a
staff member to obtain an initial Bishop score.
If the patient will be determined eligible for study entry, and following the informed
consent, randomisation into the following groups will take place:
GROUP 1: Oxytocin infusion alone (Standard Protocol). GROUP 2: insertion of the double
balloon device and concurrent oxytocin administration.
GROUP 3: Expectant management
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment