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

NCT03326557 | Completed DMC

• 1 other identifier: SibuGHO&G/17-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Induction of Labour; Previous Caesarean delivery; Foley; Membrane sweeping; Vaginal delivery

Outcome Measures

Primary Outcomes (1)

• Achievement of favourable cervix (Bishop score of 8 or more) within 48 hours of induction of labour

  The number of subjects who achieve Bishop score of 8 or more within 48 hours of induction of labour

  From the time of commencing induction until the time whereby the cervix becomes favourable (Bishop score of 8 or more), assessed up to 48 hours

Secondary Outcomes (13)

• Induction outcomes: Improvement of modified Bishop score at interval of 24 hours after induction

  From the time of commencing induction till 24 hours after induction

• Induction outcomes: Improvement of modified Bishop score at interval of 48 hours after induction

  From the time of commencing induction till 48 hours after induction

• Delivery outcomes: Mode of delivery

  At time of delivery

• Delivery outcomes: Duration of oxytocin augmentation

  From the time of administrating oxytocin augmentation until the time of delivery, assessed up to 16 hours

• Delivery outcomes: Induction to vaginal delivery interval

  From the time of induction of labour until the time of vaginal delivery, assessed up to 72 hours

Study Arms (2)

Membrane sweeping

ACTIVE COMPARATOR

Membrane sweeping involves the insertion of a digit past the internal cervical os followed by three circumferential passes of the digit causing separation of the membranes from the lower uterine segment. When the cervix is closed, a massage of the cervical surface for 15 to 30 seconds will be performed instead. Membrane sweeping will be undertaken twice a day at 8 to 10 hours apart.

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

Transcervical Foley catheter insertion

ACTIVE COMPARATOR

Transcervical Foley catheter No. 18 F will be inserted under aseptic technique into the endocervical canal surpassed beyond the internal os. The balloon will be inflated with 60 ml of sterile water and the catheter is plastered to patient's thigh with gentle traction. The catheter will be checked for its position and the traction at 6 hours interval. If it were expelled spontaneously, it would not be re-inserted. Otherwise, the catheter will be removed after 24 hours.

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

Interventions

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

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.

Membrane sweeping; Transcervical Foley catheter insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Ruptured membranes, intrauterine death, polyhydramnios, severe fetal anomalies, and multiple pregnancy.
• Contraindications for IOL eg. placenta previa, suspected macrosomia, suspected cephalopelvic disproportion, non-cephalic presentation, and obstructive pelvic masses.

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (1)

Sibu Hospital

Sibu, Sarawak, 96000, Malaysia

Location

Related Publications (1)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Soon Leong Yong, MD, Dr. ObGyn

  Department of Obstetrics and Gynaecology, Sibu Hospital, Sarawak, Malaysia.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a non-blinded study in which subjects, medical staffs, and investigators are not blinded to group assignment. This is because both IOL methods are distinctly different procedure. However, both intervention arms are considered receiving equal treatment. In term of safety, both membrane sweeping and transcervical Foley catheter are non-pharmacological in nature and thus the risk of scar rupture does not differ in both methods. In term of efficacy, there is no previous study to compare effectiveness between these two methods. Individual studies revealed that membrane sweeping is likely to reduce the need for formal IOL in post-date pregnancy and transcervical Foley catheter could improve cervical favourability.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician and Gynaecologist

Model Details: Pregnant women with one previous Caesarean section who are indicated for induction of labour (IOL) and eligible will be recruited in the study. Eligible subjects will be randomly assigned to one of the treatment groups below. * Group 1: IOL with membrane sweeping * Group 2: IOL with transcervical Foley catheter Blocked randomisation, in a block size of 6 and an allocation ratio of 1:1, will be performed using a computer-generated randomisation sequence by Research Randomizer (available online at https://www.randomizer.org/). The allocation assignment indicating "membrane sweeping" or "transcervical Foley catheter" will be sealed in sequentially numbered, opaque envelopes by principal investigator. Envelopes will be kept in a locked box in Labour Ward. When study consent is signed, the next sequential envelope will be taken out from the box and opened to determine allocation.

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: October 31, 2017
• Study Start: February 15, 2018
• Primary Completion: August 30, 2018
• Study Completion: September 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

MY (1)