AzTrials
AzTrials

Patient Acceptance of Health CarePALINCT04736342

Patients Acceptance Towards Elective Labor in Induction (PALI)

An observational study of Patient Acceptance of Health Care, run by Hanoi Obstetrics and Gynecology Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assess patients' preference, understanding regarding elective IOL and factors contribute to decision making process towards elective IOL at 39th week of gestation. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Patient Acceptance of Health Care
What is being tested?
PALI questionaire
How many people
200 participants
Where
1 siteVietnam
Study dates
15 Mar 2021to 30 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Low risk pregnant women with a gestational age at 36th week and 39th weeks

Who may be able to join

  • Maternal age ≥ 18
  • Singleton pregnancy (twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age)
  • Gestational age at 36+0 weeks to 36+6 week
  • Cephalic presentation
  • No contraindications to vaginal delivery

Who cannot join

  • Previous C-section
  • Maternal medical illness associated with increased risk of adverse pregnancy outcome (any diabetes mellitus, any hypertensive disorders, cardiac diseases, renal insufficiency, systemic lupus erythematosus, mental disorders, HIV positive, use of heparin or low-molecular weight heparin during the current pregnancy etc.)
  • Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa
  • Abnormal amniotic fluid volume:
  • Oligohydramnios (MVP < 2cm) Polyhydramnios (MVP > 10cm)
  • Abnormal fetus Fetal demise or known major fetal anomalies Fetal growth restriction (FGR) (EFW < 3% or < 10% and abnormal Doppler) Non-reassuring fetal status (no fetal movements, abnormal fetal heart rate at auscultation)

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Hanoi Obstetrics and Gynecology Hospital

    Hanoi, Hanoi, 10000

Other trials in Vietnam

About this study

Official title: Patients Acceptance Towards Elective Induction of Labor at 39th Week of Gestation (PALI)

To assess patients' preference, understanding regarding elective IOL and factors contribute to decision making process towards elective IOL at 39th week of gestation.

Read the detailed description

A normal pregnancy lasts between 37+0 to 41+6 weeks. Estimated date of delivery is set exactly at 40+0 weeks of gestation. Base on this estimation, professional society's guidelines have recommended to start inducing the labor from 41+0 to 41+6 weeks after the last menstrual period. Clinical practice during the last few decades has been moving towards this trend and postponing labor induction.

But is 40 weeks' gestational age the optimal endpoint of human pregnancy? Recent studies, however, showed different results where many of them support induction of labor at 39 weeks. A large cohort retrospective study which included information from merely 5.4 million non-anomalous live births in the United States from 2012 to 2016, though only modestly, the authors have been able to conclude that the rates of composite neonatal and maternal adverse outcomes increase from 39 through 41 weeks of gestation among low-risk parous women. Stratifying by parity, it seemed that the trend is also similar among all low-risk women no matter which parities they are in. When it comes to nulliparous women, results from a large prospective randomized control trial (the ARRIVE trial) show that induction of labor at 39 weeks in low-risk nulliparous women did not lead to significant lower frequency of a composite adverse perinatal outcome but it did result in a significant lower rate of cesarean delivery. More recently, in a review sponsored by the Cochrane library on induction of labor beyond 37 weeks' gestation has found that there is a clear reduction in perinatal death with a policy of labor induction at or beyond 37 weeks compared with expectant management, though absolute rates are small (0.4 versus 3 deaths per 1000). There were also lower caesarean rates without increasing rates of operative vaginal births and there were fewer Neonatal Intensive Care Unit admissions with a policy of induction. Base on these evidence, the American College of Obstetricians and Gynecologists has suggested "it's time to induce of labor at 39th week of gestation". It is true that although induction of labor is familiar with obstetricians, the procedure is still raising concern from patients' side. Even in the United States where patients consulting has been routinely applied, the rate of patients refuse to be induced at 39th week of gestation is about 50%. Review from Cochrane library also suggested that "Offering women tailored counselling may help them make an informed choice between induction of labor for pregnancies" . In some countries where the National Guidelines still recommends induction of labor should be considered after 41 weeks of gestation and pregnancy related decisions are driven by many identical factors such as: knowledge, traditional or cultural ones, the patients' perspective on induction of labor before 40 weeks of gestation is a challenge. Thus, the patients' understanding of the elective induction of labor and factors contribute to decision-making process towards induction of labor should be investigated in order not only to develop appropriate induction policies for the future but also scientific studies/randomized clinical trials to come.

Being tested
PALI questionaire
Keywords
Patients Acceptance, Induction of Labor, PALI
Medical subject headings
Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PALI questionaireOther

    Survey comprised of a series of multiple choice questions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients accept to undergo elective induction of labor at 39th gestational week

    Number of patients who are willing to undergo elective Induction of labor without maternal of fetal indication at 39th gestational week

    Measured: It is planned to fill the questionnaire in 30 minutes at 39th gestational week

Secondary outcomes (5)

  1. Participants knowledge

    Description of knowledge and opinions of participants towards induction of labor The knowledge about induction of labor, consisted of 13 multiple choice questions including different methods, indications, contraindications, maternal and fetal benefits/ risks of induction of labor.

    Measured: It is planned to fill the questionnaire in 30 minutes at 36th gestational week

  2. Participants opinions

    Opinion about the needs for induction of labor, consisted of 12 questions including different reasons for labor induction. Participants choose the level of agreement (strongly disagree; disagree; support; strongly support) for each questions.

    Measured: It is planned to fill the questionnaire in 30 minutes at 36th gestational week

  3. Reasons to choose or refuse elective induction of labor at 36th gestational week

    Reasons why participants choose or refuse elective induction of labor: a checklist (yes/no) of 14 reasons and an open-end question

    Measured: It is planned to fill the questionnaire in 30 minutes at 36th gestational week

  4. Reason why participants change initial decision about elective induction of labor

    Reason why participants change decision about elective induction of labor: a checklist (yes/no) of 14 reasons and an open-end question

    Measured: It is planned to fill the questionnaire in 30 minutes at 39th gestational week

  5. Factors that may affect participants' decision

    Factors that may affect participants' decision towards elective induction of labor: multiple choice questions regarding the age, ethnic group, education background, profession, financial ability, residential and cohabitation arrangement, healthcare preferences of participants

    Measured: It is planned to fill the questionnaire in 30 minutes at 36th gestational week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start15 Mar 2021
  3. Primary completion15 Mar 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736342
Sponsor's protocol ID
PSHN.0002.2021
Acronym
PALI
Status last verified
Aug 2022
First submitted
22 Jan 2021
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.

    PubMed 19623003

  • Chen HY, Grobman WA, Blackwell SC, Chauhan SP. Neonatal and Maternal Adverse Outcomes Among Low-Risk Parous Women at 39-41 Weeks of Gestation. Obstet Gynecol. 2019 Aug;134(2):288-294. doi: 10.1097/AOG.0000000000003372.

    PubMed 31306312

  • Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

    PubMed 30089070

  • Gallagher PJ, Liveright E, Mercier RJ. Patients' perspectives regarding induction of labor in the absence of maternal and fetal indications: are our patients ready for the ARRIVE trial? Am J Obstet Gynecol MFM. 2020 May;2(2):100086. doi: 10.1016/j.ajogmf.2020.100086. Epub 2020 Jan 12.

    PubMed 33345957

  • Middleton P, Shepherd E, Morris J, Crowther CA, Gomersall JC. Induction of labour at or beyond 37 weeks' gestation. Cochrane Database Syst Rev. 2020 Jul 15;7(7):CD004945. doi: 10.1002/14651858.CD004945.pub5.

    PubMed 32666584

Questions about this trial

What is this clinical trial studying?

An observational study of Patient Acceptance of Health Care, run by Hanoi Obstetrics and Gynecology Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients accept to undergo elective induction of labor at 39th gestational week (time frame: It is planned to fill the questionnaire in 30 minutes at 39th gestational week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04736342, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in