Comparing Methods for Balloon Catheter Inserting: View Guided (Speculum) Versus Manual Guided at Cervical Examination

NCT05253690 | Unknown

• 1 other identifier: 0150-21-NHR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Induction of labor is a common obstetric procedure. Foley catheter is recommended by WHO for cervical ripening. Insertion is typically speculum guided but digital insertion has been reported to be faster, better tolerated and with similar insertion success rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluated the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score\<6.

Conditions

Cervical Ripening

Keywords

labor induction; balloon catheter; cervical ripenning; speculum

Outcome Measures

Primary Outcomes (2)

• Maternal pain sensation during the procedure

  VAS (visual analog scale) SCORE scale 0-10 0-better outcome 10-worse outcome

  during the procedure

• induction to delivery duration

  hours

  through study completion, an average of 1 year

Secondary Outcomes (3)

• catheter insertion duration

  during the procedure

• maternal satisfaction- questionnaire

  during one hour after the procedure

• chorioamnionitis- fever during labor

  during labor up to 48 hours

Study Arms (2)

speculum guided

ACTIVE COMPARATOR

view-guided approach using a speculum

Procedure: balloon catheter insertion approach for labor induction

manual guided

EXPERIMENTAL

manual guided approach at cervical examination

Procedure: balloon catheter insertion approach for labor induction

Interventions

balloon catheter insertion approach for labor induction PROCEDURE

Parous women will be randomized to labor induction by view-guided approach using a speculum for catheter insersion versus manual guided catheter balloon insersion at cervical examination

manual guided; speculum guided

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singelton parous women Term pregnancy Vertex position

You may not qualify if:

• Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galil Medical Center

Nahariya, Israel

RECRUITING

Related Publications (6)

• Jonsson M, Hellgren C, Wiberg-Itzel E, Akerud H. Assessment of pain in women randomly allocated to speculum or digital insertion of the Foley catheter for induction of labor. Acta Obstet Gynecol Scand. 2011 Sep;90(9):997-1004. doi: 10.1111/j.1600-0412.2011.01197.x. Epub 2011 Jun 27.

  PMID: 21615714 BACKGROUND

• Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, Abdelwahab M, Vaughn M, Marshall K, Prasad N, Soulsby-Monroy R, Saade GR, Saad AF. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):139-145. doi: 10.1097/AOG.0000000000004182.

  PMID: 33278290 BACKGROUND

• Chia HM, Tan PC, Tan SP, Hamdan M, Omar SZ. Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial. BMC Pregnancy Childbirth. 2020 May 29;20(1):330. doi: 10.1186/s12884-020-03029-0.

  PMID: 32471369 BACKGROUND

• Liu X, Wang Y, Zhang F, Zhong X, Ou R, Luo X, Qi H. Double- versus single-balloon catheters for labour induction and cervical ripening: a meta-analysis. BMC Pregnancy Childbirth. 2019 Oct 16;19(1):358. doi: 10.1186/s12884-019-2491-4.

  PMID: 31619189 BACKGROUND

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.

  PMID: 31623014 BACKGROUND

• Abu Shqara R, Nakhleh Francis Y, Haj H, Markdorf S, Lowenstein L, Frank Wolf M. Digital vs speculum-guided catheter balloon insertion for cervical ripening in multiparas: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100943. doi: 10.1016/j.ajogmf.2023.100943. Epub 2023 Mar 25.

  PMID: 36972835 DERIVED

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Maya Wolf, MD

  Galilee Medical Center

  STUDY DIRECTOR

Central Study Contacts

Maya Wolf, MD

CONTACT

972-50-7887800; mayaw@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The obstetrician evaluating labor progress is blinded for type of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of fetal maternal unit

Model Details: Randomized control trial

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 24, 2022
• Study Start: January 10, 2022
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)