Patients Acceptance Towards Elective Labor in Induction (PALI)

Patient Acceptance of Health Care Clinical Trial

— PALI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736342
• Other study ID #: PSHN.0002.2021
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Hanoi Obstetrics and Gynecology Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

1. Previous C-section

2. 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.)

3. Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa

4. Abnormal amniotic fluid volume:

Oligohydramnios (MVP < 2cm) Polyhydramnios (MVP > 10cm)

5. 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)

Related Conditions & MeSH terms

• Patient Acceptance of Health Care

Intervention

Other:
• PALI questionaire
Survey comprised of a series of multiple choice questions

Locations

Country	Name	City	State
Vietnam	Hanoi Obstetrics and Gynecology Hospital	Hanoi	Hà N?i

Sponsors (2)

Lead Sponsor	Collaborator
Hanoi Obstetrics and Gynecology Hospital	M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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 Sh — View Citation

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:CD004945. doi: 10.1002/14651858.CD004945.pub5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	It is planned to fill the questionnaire in 30 minutes at 36th gestational week
Secondary	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.	It is planned to fill the questionnaire in 30 minutes at 36th gestational week
Secondary	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	It is planned to fill the questionnaire in 30 minutes at 36th gestational week
Secondary	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	It is planned to fill the questionnaire in 30 minutes at 39th gestational week
Secondary	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	It is planned to fill the questionnaire in 30 minutes at 36th gestational week