Comparing two methods of labour induction in term pregnant women who had one previous Caesarean delivery and history of vaginal birth(s)
| ISRCTN | ISRCTN15310448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15310448 |
| Secondary identifying numbers | MREC ID: 2021426-10091 |
- Submission date
- 10/08/2021
- Registration date
- 19/08/2021
- Last edited
- 11/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Labour induction is the stimulation of uterine contractions during pregnancy before labour begins on its own to achieve a vaginal birth. It is done because earlier delivery is considered to be safer than allowing the pregnancy to continue in certain cases, and occasionally for logistic or maternal preference.
Induction of labour in women with a Caesarean section is associated with a risk of scar rupture and a higher failure rate resulting in a repeat Caesarean section. However, it is considered a safe process when conducted in a well-resourced setting after careful consideration and counselling. The standard method of induction can be medical or mechanical. In medically induced labour for unfavourable cervix, a prostaglandin will be given into the vagina. Prostaglandin will soften the cervix and can cause contractions. A new preparation of prostaglandin has been developed which is in vaginal insert form. It contains a reservoir that slowly releases the drug; compared to vaginal tablet forms where absorption can be too fast leading to intense contractions. If intense contractions are produced, the insert can be easily removed by pulling out the thread.
Mechanically induced labour uses physical pressure to stimulate the cervix. A Foley catheter is commonly used in this method. The tube is inserted through the cervix and the balloon is filled with water and the outside section of the tube is taped to the woman's thigh to apply gentle downward pressure. The pressure of the balloon causes softening and opening (ripening) of the cervix, but usually without contractions. It is placed for 24 hours or removed earlier if medically indicated. Breaking the waters and an oxytocin drip to produce contractions is more often needed in labour induction with the Foley catheter, compared to when prostaglandins are used.
This study aims to compare the use of the Foley catheter and dinoprostone controlled released vaginal insert (a type of prostaglandin) in women with full-term pregnancies who have previously had one Caesarean section and a history of vaginal birth(s). The two methods of labour induction will be compared in terms of caesarean section rate.
Who can participate?
Women at over 37 weeks of pregnancy who have had one previous Caesarean and history of vaginal birth(s) and who need induction of labour.
What does the study involve?
Participants will be randomly allocated to the dinoprostone controlled-release vaginal insert group or the Foley catheter group. In the dinoprostone group, the insert will be placed in the vagina. For women in the Foley catheter group, the catheter will be inserted and the balloon inflated with 60 ml of water. In both groups, the vaginal insert or Foley catheter will be removed if there are any problems or if it is still inside the vagina after 24 hours.
What are the possible benefits and risks of participating?
A possible benefit is a lower caesarean section rate, reducing repeated caesarean section complications for mother and baby. There is a small risk of failure of induction and a Caesarean delivery will be needed. The vaginal insert can cause uterine hyperstimulation, which involves very strong and long-lasting contractions or contractions every 2 minutes on average. This can result in problems for the baby or rupture of the womb. If uterine hyperstimulation occurs, the insert must be removed immediately and a tocolytic agent (medication to reduce uterine contraction) can be considered.
Where is the study run from?
University Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
April 2021 to December 2022
Who is funding the study?
University Malaya (Malaysia)
Who is the main contact?
1. Dr Nor Dalila Shamsuddin
dalila.shamsuddin@gmail.com
2. Prof. Dr Tan Peng Chiong
pctan@um.edu.my
Contact information
Scientific
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)379494422 |
|---|---|
| dalila.sham@ummc.edu.my |
Scientific
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60133267990 |
|---|---|
| dalila.shamsuddin@gmail.com |
Study information
| Study design | Randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40269_PIS_V2_01Jun21.docx |
| Scientific title | Induction of labour in one previous Caesarean delivery and history of vaginal birth(s) with Foley catheter versus controlled-release dinoprostone vaginal insert: a randomised trial |
| Study acronym | FocaCer |
| Study objectives | Induction of labour with controlled-release dinoprostone vaginal insert in women with one previous caesarean delivery and history of vaginal birth(s) will result in lower caesarean rate and higher patient satisfaction with their birth process. |
| Ethics approval(s) | Approved 01/07/2021, University of Malaya Medical Centre Medical Research Ethics Committee (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +60 (0)3 7949 8473; email: not applicable), ref: MREC ID: 2021426-10091 |
| Health condition(s) or problem(s) studied | Labour induction |
| Intervention | This study is a randomised trial to compare Foley catheter with controlled-release dinoprostone vaginal Insert for induction of labour in women with one previous caesarean delivery and history of vaginal birth(s). The decision to proceed with induction of labour is made by the care provider based on standard clinical grounds and specific consenting with the option for repeat Caesarean always on offer as an alternative. Pregnant women with one previous caesarean delivery and history of vaginal birth(s) who has been decided for induction of labour and who fulfil the inclusion/exclusion criteria will be recruited. Those eligible will be counselled regarding the study and a patient information sheet will also be given. Time will be given for the patient to make her decision to participate in this study. If the woman agrees to participate in this study, written consent will be obtained. Women who choose not to participate will receive standard care and participants who decided to withdraw may do so without having to give a reason and their care will not be affected. On admission, a pre-induction cardiotocography (CTG) and assessment of Bishop Score will be carried out. Participants are excluded from the study if the CTG is non-reassuring or Bishop score is 6 or more. Participants who are suitable for the study will be randomised into two groups (Foley catheter or controlled-release dinoprostone vaginal insert). The randomization sequence will be generated using a random number generator at the random.org website. In the Foley catheter group, participants will be induced using a 16F Foley catheter under the aseptic technique. The catheter balloon will be inflated with 60 ml of sterile water and gentle traction is applied until the balloon meets resistance. The external end of the catheter is spigot and then strapped to the thigh without additional tension. The Foley catheter will be removed if there is a spontaneous rupture of membrane, abnormal CTG, uterine hyperstimulation or tachysystole, excessive pain or vaginal bleeding, or after 24 hours of placement While in the controlled-release dinoprostone vaginal insert group, participants will be induced with a controlled-release dinoprostone vaginal Insert. The insert will be inserted under sterile technique and only will be removed if there is a spontaneous rupture of membrane, abnormal CTG, uterine hyperstimulation or tachysystole, excessive pain or vaginal bleeding, a side effect of dinoprostone such as nausea, vomiting, hypotension or tachycardia and after 24 hours of placement. In both groups, CTG monitoring will be performed after the intervention and subsequent CTG will be carried out at a minimum of every 6 hours whilst the patient is on the intervention device or as per care provider in interim event (i.e. regular contraction suggestive of labour progression). Participants in both arms will be assessed after 24 hours and the catheter or insert will be removed if not dislodged spontaneously. After 24 hours of intervention with foley or insert, if the cervix is favourable, an amniotomy will be carried out when the cervical dilatation is at least 2-3 cm. If the cervix is not favourable after 24 hours, the participants will be counselled and given the option of continuing with labour induction or proceeding with repeat caesarean delivery. If the patient opts for the continuation of induction of labour, a cross over to the other intervention can be initiated after a discussion with the care provider. Beyond 48 hours, if the cervix is still unfavourable, there will be a further discussion between the patient and care provider with the consultant. Intrapartum management of participant’s labour and decision making on delivery is at the discretion of the care provider according to standard practical practice. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Caesarean section rate collected from patients’ medical records after the patient has delivered and measured after the completed sample size for this study |
| Secondary outcome measures | Maternal outcomes: 1. Use of additional method for cervical ripening, taken from patients’ medical records after delivery 2. Bishop score upon first assessment upon removal of induction of labor method 3. Spontaneous rupture of membrane or amniotomy, taken from patients’ medical records after delivery 4. Use of oxytocin for intrapartum augmentation, taken from patients’ medical records after delivery 5. Duration of oxytocin use, taken from patients’ medical records after delivery 6. Type of analgesia in labor, taken from patients’ medical records after delivery 7. Estimated blood loss for delivery, taken from patients’ medical records after delivery 8. Fever ≥38°C, taken from patients’ medical records and collected from initiation of induction of labour until patient discharge 9. Complications (scar rupture, blood transfusion, maternal admission to ICU/HDU, hysterectomy, re-laparotomy, others), taken from patients’ medical records during induction of labour, intrapartum and postpartum until patient discharge 10. Uterine hyperstimulation syndrome, taken from patients’ medical records from first 24 hours from initiation of induction of labour and obtained after delivery 11. Terbutaline use, taken from patients’ medical records after delivery 12. Maternal satisfaction with induction method using a visual numerical rating scale (scored from 0 to 10), obtained upon removal/dislodge of the induction device 13. Pain during the insertion of the device, measured using the visual analogue score (VAS) as soon as possible after placement of induction device Neonatal outcomes: 1. APGAR score at 1 and 5 minutes, measured using the APGAR score scoring system after delivery 2. Arterial cord pH, taken from arterial cord blood gas and obtained after delivery 3. Birth weight, taken from patients’ medical records after delivery 4. Neonatal admission and indication, taken from patients’ medical records after delivery 5. Neonatal complications, taken from patients’ medical records after delivery |
| Overall study start date | 01/04/2021 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 60 patients with 30 in each arm |
| Key inclusion criteria | 1. Scheduled induction of labour 2. One previous scar 3. History of vaginal birth(s) 4. Aged 18 years and above 5. Gestational age of >37 weeks at enrolment 6. Unfavorable cervix (Bishop Score <6) 7. Singleton pregnancy 8. Cephalic presentation 9. Reassuring pre-induction fetal cardiotocography (CTG) 10. Intact membranes 11. Absence of significant contraction ≥2 in 10 minutes |
| Key exclusion criteria | 1. Preference for elective repeated caesarean section 2. Allergic to latex 3. Allergic to prostaglandin 4. Inability to give consent 5. Known gross fetal anomaly 6. Absolute contraindication to vaginal delivery 7. Estimated fetal weight of <2 kg or ≥4 kg |
| Date of first enrolment | 23/08/2021 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
University/education
Obstetrics and Gynaecology Department
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)3 7949 2473 |
|---|---|
| grow@ummc.edu.my | |
| Website | https://www.um.edu.my/ |
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The raw data generated during and/or analysed during the current study are/will be available upon request from Nor Dalila Shamsuddin (dalila.sham@ummc.edu.my) and the results will be available publicly at https://v1.nmrr.gov.my/fwbLoginPage.jsp under the directory of medical research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 01/06/2021 | 16/08/2021 | No | Yes |
| Protocol file | version 2 | 02/06/2021 | 16/08/2021 | No | No |
Additional files
Editorial Notes
11/08/2023: A scientific study contact was added.
16/08/2021: Trial's existence confirmed by the Medical Ethics Committee University Malaya and National Medical Research Register.
