Patients Acceptance Towards Elective Labor in Induction (PALI)

NCT04736342 | Completed

• 1 other identifier: PSHN.0002.2021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Acceptance of Health Care

Keywords

Patients Acceptance; Induction of Labor; PALI

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

• Participants knowledge

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

• Participants opinions

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

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

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

• Reason why participants change initial decision about elective induction of labor

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

• Factors that may affect participants' decision

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

Interventions

PALI questionaire OTHER

Survey comprised of a series of multiple choice questions

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hanoi Obstetrics and Gynecology Hospital: lead
• Mỹ Đức Hospital: collaborator

Study Sites (1)

Hanoi Obstetrics and Gynecology Hospital

Hanoi, Hanoi, 10000, Vietnam

Location

Related Publications (5)

• 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.

  PMID: 19623003 RESULT

• 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.

  PMID: 31306312 RESULT

• 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.

  PMID: 30089070 RESULT

• 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.

  PMID: 33345957 RESULT

• 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.

  PMID: 32666584 RESULT

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anh Nguyen Duy, PhD. MD

  Hanoi Obstetric and Gynecology Hospital

  STUDY DIRECTOR

• Ha Nguyen Thi Thu, PhD. MD

  Hanoi Obstetric and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

• Minh Chau Ngoc, MD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

• Ben W Mol, PhD. MD

  Monash University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 3, 2021
• Study Start: March 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: June 30, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)