Does providing information about induction of labour at 39 weeks earlier in pregnancy affect women's decision?
| ISRCTN | ISRCTN10921283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10921283 |
| Sponsor | University Malaya Medical Centre |
| Funder | Universiti Malaya |
- Submission date
- 24/08/2026
- Registration date
- 26/08/2026
- Last edited
- 26/08/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Elective induction of labour at 39 weeks is one option for women with uncomplicated pregnancies. Some women choose induction, while others prefer to wait for labour to begin naturally. This study aims to find out whether providing balanced, evidence-based information about induction earlier in pregnancy influences women's decision regarding elective induction at 39 weeks.
Who can participate?
Low-risk nulliparous women receiving antenatal care at University Malaya Medical Centre (UMMC) between 34+0 and 36+6 weeks of pregnancy at recruitment.
What does the study involve?
Participants will be randomly assigned to one of two groups. The intervention group will receive an evidence-based information leaflet about elective induction at 39 weeks at 34+0–36+6 weeks and may read and discuss it at home. The control group will receive routine antenatal care without the leaflet at this stage.
At 37+0–38+6 weeks, both groups will receive the same leaflet and standardized counselling about induction at 39 weeks and expectant management. Participants will then complete a questionnaire assessing their decision-making experience. The main outcome is whether they accept or decline an appointment for elective induction at 39 weeks. Decision quality, maternal satisfaction, actual labour management, and maternal and neonatal outcomes will also be assessed.
What are the possible benefits and risks of participating?
Participants may find the information helpful in understanding their options regarding induction of labour. However, there is no guarantee of direct personal benefit. There are no expected physical risks from participating. The main inconvenience is the time required to read the information and complete the questionnaires.
Where is the study run from?
The University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
When is the study starting and how long is it expected to run for?
Participant recruitment will begin after the required ethical and regulatory approvals and prospective trial registration have been completed. Individual participation is expected to last approximately 4–8 weeks, from recruitment at 34–36+6 weeks until discharge after delivery.
Participant recruitment is planned from 1 September 2026 to 1 May 2027, with the study expected to be completed by 31 May 2027. Individual participation will last approximately 4–8 weeks, from recruitment at 34–36+6 weeks of pregnancy until discharge from hospital after delivery.
Who is funding the study?
The study is funded by the Department of Obstetrics and Gynaecology, University Malaya Medical Centre (UMMC).
Who is the main contact?
Dr Siti Nurafiqah Hanani Binti Shiekh Anuar, Department of Obstetrics and Gynaecology, University Malaya Medical Centre (UMMC), hanani.anuar@ummc.edu.my
Contact information
Principal investigator
Department of Obstetric and Gynaecology, University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia
| Phone | +60 0172033201 |
|---|---|
| hanani.anuar@ummc.edu.my |
Scientific
Department of Obstetric and Gynaecology, University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia
| Phone | +60 0123052970 |
|---|---|
| tanpengchiong@yahoo.com |
Public
Department of Obstetric and Gynaecology, University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia
| Phone | +60 0172033201 |
|---|---|
| hananianuar19@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Health services research |
| Participant information sheet | 50138_PIS_v3_19June2026.pdf |
| Scientific title | Impact of advance provision of an evidence-based information leaflet on women's decision regarding elective induction of labour at 39 weeks among low-risk nulliparous women: a randomized controlled trial |
| Study acronym | AHEAD-IOL |
| Study objectives | Primary objective: To determine whether advance provision of an evidence-based information leaflet regarding elective induction of labour at 39 weeks influences women's decision to accept or decline an appointment for elective induction of labour at 39 weeks, compared with provision of the same information at the time of routine antenatal counselling. Secondary objectives: To compare decision quality, maternal satisfaction with labour and birth experience, actual labour management, and maternal and neonatal outcomes between the intervention and control groups. |
| Ethics approval(s) |
Approved 21/01/2026, Universiti Malaya Medical Center-Medical Research Ethics Committee (UMMC-MREC) (Medical Research Ethics Unit (MREU) 3rd Floor, Main Tower Universiti Malaya Medical Centre Lembah Pantai, Kuala Lumpur, 59100, Malaysia; +60379493209; ummc-mrec@ummc.edu.my), ref: 2025823-15515 |
| Health condition(s) or problem(s) studied | Decision-making regarding elective induction of labour at 39 weeks versus expectant management among low-risk nulliparous women |
| Intervention | Randomisation Participants will be randomly allocated in a 1:1 ratio using a computer-generated randomisation sequence. Variable block sizes of four, six and eight will be used. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared by an independent individual who is not involved in participant recruitment, intervention delivery or outcome assessment. Due to the nature of the intervention, participants and healthcare providers cannot be blinded to group allocation. Intervention group: Participants will receive a bilingual, evidence-based information leaflet regarding elective induction of labour at 39 weeks at recruitment, between 34+0 and 36+6 weeks' gestation. The leaflet provides balanced information regarding elective induction at 39 weeks and expectant management, including benefits and risks, ARRIVE trial findings, methods of induction, pain relief options, and maternal and neonatal outcomes. Participants will be encouraged to read the leaflet at home and may discuss the information with their partner or family members. Control group: Participants will receive routine antenatal care without the study information leaflet at recruitment. At the routine antenatal follow-up visit between 37+0 and 38+6 weeks' gestation, participants in both groups will receive the same evidence-based information leaflet and standardized counselling regarding elective induction of labour at 39 weeks versus expectant management. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/05/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 186 |
| Key inclusion criteria | 1. Age ≥18 years 2. Nulliparous woman (no previous pregnancy beyond 22 weeks' gestation) 3. Singleton pregnancy 4. Gestational age between 34+0 and 36+6 weeks at recruitment 5. Cephalic presentation 6. Intact membranes 7. Low-risk pregnancy without known maternal, fetal, or obstetric complications requiring planned delivery before 39 weeks 8. Able to read and understand English or Malay 9. Able and willing to provide written informed consent |
| Key exclusion criteria | 1. Previous caesarean delivery or previous uterine surgery contraindicating labour 2. Contraindication to vaginal birth (e.g., placenta praevia, major uterine anomaly) 3. Current indication for immediate induction of labour or emergency delivery 4. Planned elective induction of labour or caesarean delivery for maternal or fetal indications 5. Major congenital fetal anomaly 6. Non-reassuring fetal status, including suspected fetal growth restriction (FGR), severe small-for-gestational-age (SGA) fetus requiring planned delivery, abnormal fetal surveillance (e.g., abnormal umbilical artery Doppler or cardiotocography), or other fetal conditions requiring obstetric intervention 7. Regular uterine contractions suggestive of established labour 8. Maternal medical disorders requiring intervention or planned delivery (e.g., pre-existing diabetes mellitus, gestational diabetes requiring medication, chronic hypertension, gestational hypertension, pre-eclampsia) 9. Inability to read or understand English or Malay |
| Date of first enrolment | 01/09/2026 |
| Date of final enrolment | 01/05/2027 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 24/08/2026 | No | No | ||
| Other files | version 3 | 19/06/2026 | 24/08/2026 | No | No |
| Other files | version 3 | 19/06/2026 | 24/08/2026 | No | No |
| Participant information sheet | version 3 | 19/06/2026 | 24/08/2026 | No | Yes |
| Protocol file | version 3 | 19/06/2026 | 24/08/2026 | No | No |
Additional files
- 50138_PIS_v3_19June2026.pdf
- Participant information sheet
- 50138_Protocol_v3_19June2026.pdf
- Protocol file
- 50138_ARRIVE leaflet.pdf
- Other files
- 50138_CaseReportForm_v3_19June2026.pdf
- Other files
- 50138_Consent Form_v3_19June2026.pdf
- Other files
Editorial Notes
25/08/2026: Study’s existence confirmed by the University of Malaya Medical Centre - Medical Research Ethics Committee (UMMC-MREC).
