search
Back to results

Mechanical Dilation of the Cervix in a Scarred Uterus (MEDICS)

Primary Purpose

Pregnancy Related, Labor Complication, Cesarean Section; Dehiscence

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Cervical balloon
Prostaglandins
Sponsored by
Ministry of Health, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring caesarean, uterus

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female ≥ 21 years of age at booking visit
  • 1 previous uncomplicated lower segment caesarean section (CS)
  • Aiming for TOLAC
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
  • Singleton pregnancy
  • Gestational age >37 weeks
  • Understands risk of TOLAC
  • Eligible for induction of labour for the standard obstetric indications, including post-date or post-term pregnancies at 40-41 completed weeks of gestation
  • Unfavourable Bishop's Score ≤ 5 requiring cervical priming
  • Previous uterine surgery, including simple myomectomy, where there is no contraindication to TOLAC
  • Reactive CTG pre-induction
  • Ruptured membranes

Exclusion Criteria:

  • Refusal to participate
  • Women with 2 or more previous CS
  • Previous classical or lower segment vertical incision, or inverted T or J incision in the previous caesarean delivery
  • Previous uterine surgery with contra-indication to future TOLAC
  • Maternal contraindication for vaginal delivery
  • Fetal contraindication for vaginal delivery or major fetal abnormality
  • Malpresentation or cord presentation
  • Placenta praevia <20mm from internal os
  • Chorioamnionitis
  • Antepartum haemorrhage of undetermined origin AND deemed a contraindication for TOLAC
  • Suspected fetal macrosomia (estimated weight on ultrasound >4kg) AND deemed a contraindication for TOLAC
  • Congenital uterine abnormality
  • Multifetal pregnancy
  • Latex allergy or poorly-controlled asthma

Sites / Locations

  • National University Hospital, SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cervical Balloon

Prostaglandin

Arm Description

Transcervical 2-way 18 French (18F) single balloon Foley catheter, applied using a sponge-holding forceps into the cervical canal with the balloon inflated to a minimum of 30ml and maximum of 60ml with sterile water or saline [1]. This will be administered once during the study and will be retained for a maximum of 12 hours within the 24 hour study period.

Prostaglandin E2 (Prostin®) 3mg tablet, placed high in the vaginal fornix. This will be administered per vaginum once in the first 6 hours; a second dose is administered at the discretion of the clinician / clinical team 6 hours after the first pessary, for a cumulative total of 6mg within the 24 hour study period.

Outcomes

Primary Outcome Measures

Improvement in Bishops score
Assess for increase in Bishops score from baseline of <5 (Unfavourable) to >6

Secondary Outcome Measures

Achieving active labour
Achieving delivery
Number of PGE tablets required
For the prostin arm - How many tablets required, ie 1 or 2 to achieve improvement in Bishops score
Number of times the foley catheter (cervical balloon) needs to be readjusted
Numerical number of the times the foley catheter needs to be removed, replaced or readjusted
Mode of delivery
Successful vaginal birth after previous caesarean section, or emergency caesarean section
Maternal complications
failed device insertion, inability to void urine following insertion, intolerance of device and early removal, vaginal bleeding after insertion of device, spontaneous membrane rupture.
Fetal complications
fetal distress, meconium-stained liquor, malpresentation, neonatal Apgar score of <7 at 5 minutes, cord blood pH of ≤7.0, admission to NICU, neonatal hypoxic-ischaemic encephalopathy, neonatal death.
Infectious complications
intrauterine infection, maternal sepsis (e.g. endometritis, UTI), neonatal sepsis, maternal pyrexia, onset of antibiotics
Labour complications
uterine hyperstimulation (i.e. >5 contractions / 10mins with abnormal CTG), placental abruption, cord prolapse, postpartum haemorrhage, 3rd / 4th degree perineal tears, uterine rupture.

Full Information

First Posted
March 13, 2018
Last Updated
October 6, 2019
Sponsor
Ministry of Health, Singapore
Collaborators
Department of Obstetrics and Gynaecology, National University Hospital, Yong Loo Lin School of Medicine, National University Hospital, Singapore, National University of Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT03471858
Brief Title
Mechanical Dilation of the Cervix in a Scarred Uterus
Acronym
MEDICS
Official Title
MEchanical DIlatation of the Cervix in a Scarred Uterus (MEDICS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Singapore
Collaborators
Department of Obstetrics and Gynaecology, National University Hospital, Yong Loo Lin School of Medicine, National University Hospital, Singapore, National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine if mechanical labour induction can offer a safer and effective alternative to prostaglandins to women with previous caesarean section attempting trial of labour after caesarean (TOLAC).
Detailed Description
There is good evidence to show that induction of labour with a transcervical balloon compares favourably with the use of prostaglandins.The cervical balloon works by softening & stretching the cervix mechanically & stimulates the release of endogenous prostaglandins. When compared with prostaglandins, meta-analysis have shown that for TCB induction, there is no significant different in caesarean section rates (27% vs 25%) with a reduced risk of hyperstimulation with fetal heart rate change (0.4% vs 3%). Further, when compared against induction with misoprostol, induction with a Foley catheter balloon was found to have a lower rate of caesarean section for a non-reassuring fetal heart rate (RR 0.54, 95% CI 0.37-0.79) and a fewer vaginal instrumental deliveries (RR 0.74, 95% CI 0.55-0.95) [41]. One randomized controlled trial of 824 women with no previous caesarean section comparing foley catheter balloon with a prostaglandin E2 gel demonstrated no difference in caesarean section rates & 2 cases of uterine rupture or perforation in the prostaglandin E2 arm but not in the foley catheter balloon arm. Another study involving 1859 women comparing foley catheter balloon with oral misoprostol showed no difference in caesarean section rates or complications. It was, however, noted that induction with foley catheter balloon more likely required oxytocin induction at 80.3% vs 68.4% for misoprostol. While there were earlier concerns of an increase in infectious morbidity when using mechanical induction of labour due to the presence of a foreign body, more recent RCTs & meta-analysis have shown that there is no significant increase. One of the main concerns for induction of labour in patients with a previous uterine scar is an increased risk of uterine rupture. One observational study of 20,095 women quoted a risk of uterine rupture in spontaneous labour to be 0.52% & in prostaglandin-induced labour to be 0.77%. Another observational study involving 33,699 women quoted a risk of 0.4% and 1% respectively. While there are also studies which suggest that there is no significant increase in the rate of uterine rupture, many professional bodies have discouraged prostaglandin-induction in women with previous scars. Due to lower levels of hyperstimulation that could lead to fetal distress or uterine rupture, trans cervical balloon induction has found itself as a possible, safer means of induction of labour for women who are keen for vaginal birth after caesarean and are agreeable with induction. Most RCTs were small in size & did not demonstrate any uterine rupture or dehiscence. However, 2 retrospective cohort studies involving a size of 2479 & 208 women respectively showed a uterine rupture rate of about 0.5%. trans cervical balloon induction appears to be a safe method for inducing consenting women keen for vaginal birth after caesarean and this study will contribute towards this body of evidence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Labor Complication, Cesarean Section; Dehiscence
Keywords
caesarean, uterus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical Balloon
Arm Type
Active Comparator
Arm Description
Transcervical 2-way 18 French (18F) single balloon Foley catheter, applied using a sponge-holding forceps into the cervical canal with the balloon inflated to a minimum of 30ml and maximum of 60ml with sterile water or saline [1]. This will be administered once during the study and will be retained for a maximum of 12 hours within the 24 hour study period.
Arm Title
Prostaglandin
Arm Type
Active Comparator
Arm Description
Prostaglandin E2 (Prostin®) 3mg tablet, placed high in the vaginal fornix. This will be administered per vaginum once in the first 6 hours; a second dose is administered at the discretion of the clinician / clinical team 6 hours after the first pessary, for a cumulative total of 6mg within the 24 hour study period.
Intervention Type
Device
Intervention Name(s)
Cervical balloon
Other Intervention Name(s)
Foley Balloon Catheter
Intervention Description
To assess if a cervical balloon catheter (foleys catheter) for mechanical induction of labour is comparable to prostaglandin usage for induction of labour in women who have had a previous caesarean section.
Intervention Type
Drug
Intervention Name(s)
Prostaglandins
Other Intervention Name(s)
Prostin
Intervention Description
Prostin will be used in the control arm.
Primary Outcome Measure Information:
Title
Improvement in Bishops score
Description
Assess for increase in Bishops score from baseline of <5 (Unfavourable) to >6
Time Frame
24hours
Secondary Outcome Measure Information:
Title
Achieving active labour
Description
Achieving delivery
Time Frame
Within 24-48hours of intervention
Title
Number of PGE tablets required
Description
For the prostin arm - How many tablets required, ie 1 or 2 to achieve improvement in Bishops score
Time Frame
Within 24-48hours of intervention
Title
Number of times the foley catheter (cervical balloon) needs to be readjusted
Description
Numerical number of the times the foley catheter needs to be removed, replaced or readjusted
Time Frame
Within 24-48hours of intervention
Title
Mode of delivery
Description
Successful vaginal birth after previous caesarean section, or emergency caesarean section
Time Frame
Within 24-48hours of intervention
Title
Maternal complications
Description
failed device insertion, inability to void urine following insertion, intolerance of device and early removal, vaginal bleeding after insertion of device, spontaneous membrane rupture.
Time Frame
Within 24-48hours of intervention
Title
Fetal complications
Description
fetal distress, meconium-stained liquor, malpresentation, neonatal Apgar score of <7 at 5 minutes, cord blood pH of ≤7.0, admission to NICU, neonatal hypoxic-ischaemic encephalopathy, neonatal death.
Time Frame
Within 24-48hours of intervention
Title
Infectious complications
Description
intrauterine infection, maternal sepsis (e.g. endometritis, UTI), neonatal sepsis, maternal pyrexia, onset of antibiotics
Time Frame
Within 24-48hours of intervention
Title
Labour complications
Description
uterine hyperstimulation (i.e. >5 contractions / 10mins with abnormal CTG), placental abruption, cord prolapse, postpartum haemorrhage, 3rd / 4th degree perineal tears, uterine rupture.
Time Frame
Within 24-48hours of intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female ≥ 21 years of age at booking visit 1 previous uncomplicated lower segment caesarean section (CS) Aiming for TOLAC Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Singleton pregnancy Gestational age >37 weeks Understands risk of TOLAC Eligible for induction of labour for the standard obstetric indications, including post-date or post-term pregnancies at 40-41 completed weeks of gestation Unfavourable Bishop's Score ≤ 5 requiring cervical priming Previous uterine surgery, including simple myomectomy, where there is no contraindication to TOLAC Reactive CTG pre-induction Ruptured membranes Exclusion Criteria: Refusal to participate Women with 2 or more previous CS Previous classical or lower segment vertical incision, or inverted T or J incision in the previous caesarean delivery Previous uterine surgery with contra-indication to future TOLAC Maternal contraindication for vaginal delivery Fetal contraindication for vaginal delivery or major fetal abnormality Malpresentation or cord presentation Placenta praevia <20mm from internal os Chorioamnionitis Antepartum haemorrhage of undetermined origin AND deemed a contraindication for TOLAC Suspected fetal macrosomia (estimated weight on ultrasound >4kg) AND deemed a contraindication for TOLAC Congenital uterine abnormality Multifetal pregnancy Latex allergy or poorly-controlled asthma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Choo Soe-na, Dr
Email
soe_na_choo@nuhs.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Citra Mattar, Dr
Phone
+6567725555
Facility Information:
Facility Name
National University Hospital, Singapore
City
Singapore
ZIP/Postal Code
679973
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Citra Mattar, Dr
Phone
67725555

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31699720
Citation
Choo SN, Kanneganti A, Abdul Aziz MNDB, Loh L, Hargreaves C, Gopal V, Biswas A, Chan YH, Ismail IS, Chi C, Mattar C. MEchanical DIlatation of the Cervix-- in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery. BMJ Open. 2019 Nov 6;9(11):e028896. doi: 10.1136/bmjopen-2019-028896.
Results Reference
derived

Learn more about this trial

Mechanical Dilation of the Cervix in a Scarred Uterus

We'll reach out to this number within 24 hrs