Membrane Sweeping Versus Transcervical Foley Catheter for Induction of Labour in Women With Previous Caesarean Delivery

Summary

Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five pregnancies requires induction of labour. The use of non-pharmacological methods (methods without using medication) has been gaining popularity for women who are not good candidates, such as women with previous Caesarean scar, for an induction with medications such as prostaglandin. Labour induction with prostaglandin carries higher risk of uterine rupture and thus it is not routinely offered to women with previous Caesarean delivery in Sibu Hospital. Non-pharmacological methods of induction of labour appear to be safe in women with previous Caesarean delivery. However, various methods are available and the efficacy among them remain in doubt.

In Sibu Hospital, membrane sweeping, which is a type of non-pharmacological method, is routinely offered to women with previous Caesarean delivery who require induction of labour. However, membrane sweeping may not exert its labour induction effect immediately and the delivery may be delayed by up to 8 days. This may render a proportion of women to resort to repeated Caesarean section for failed induction.

Transcervical Foley catheter insertion is another non-pharmacological methods for labour induction. Foley catheter, which is made from latex rubber, is inserted into the womb. The balloon will be inflated and this put pressure on the cervix and encourages dilatation. This method may successfully stimulates labour and the catheter falls out once the cervix dilates to 3 centimeters.

The benefits of the Foley catheter:

* A favourable and safe option for mothers who are hoping for a vaginal birth after Caesarean. It is estimated that 4-7 in 10 women with previous Caesarean undergoing labour induction with Foley catheter will have successful vaginal births.
* Cause the cervix to mechanically open without involving medication.
* Reduced risk of uterine rupture compared to induction with prostaglandin.
* Less risk of fetal distress compared to induction with prostaglandin.

The risks of Foley catheter:

* Vaginal bleeding (1.8%)
* Pain requiring removal of catheter (1.7%)
* Baby moving from head down to breech (1.3%)
* Fever (1%) which is lower than induction with prostaglandin.
* The risk of uterine rupture is similar to women undergoing spontaneous vaginal birth after Caesarean.

The aim of this study is to compare the effectiveness of two types of non-pharmacological methods, ie. membrane sweeping and transcervical Foley catheter for induction of labour in women with previous Caesarean delivery.

Conditions

• Labour, Induced
• Vaginal Birth After Caesarean

Interventions

PROCEDURE

Membrane Sweeping versus Transcervical Foley Catheter for Induction of Labour in Women with Previous Caesarean Delivery

Subjects undergoing induction of labour (IOL) will be randomly assigned to two interventional arms (Group 1: membrane sweeping or Group 2: transcervical Foley catheter insertion). Before IOL, modified Bishop score will be assessed for cervical favourability. After 24 hours of IOL, improvement of modified Bishop score will be reassessed. If the cervix is favourable, amniotomy will be performed followed by augmentation with intravenous oxytocin. If the cervix is still unfavourable and amniotomy is impossible, membrane sweeping will be continued for one more day in Group 1 whereas conservative management will be undertaken for one day in Group 2. Suitability for amniotomy will be reassessed on the next day. After amniotomy, subsequent intrapartum management will be based on the hospital protocol. If amniotomy is still impossible after 2 days of IOL, the ward Obstetrician will discuss with women regarding option of Caesarean section.

Sponsors & Collaborators

• Ministry of Health, Malaysia

  lead OTHER_GOV

Principal Investigators

• Soon Leong Yong, MD, Dr. ObGyn · Department of Obstetrics and Gynaecology, Sibu Hospital, Sarawak, Malaysia.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-15

Primary Completion

2018-08-30

Completion

2018-09-01

Countries

• Malaysia

Study Locations