Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05253690
Other study ID # 0150-21-NHR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date January 10, 2025

Study information

Verified date March 2022
Source Western Galilee Hospital-Nahariya
Contact Maya Wolf, MD
Phone 972-50-7887800
Email mayaw@gmc.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Globally, there has been an increase in birth-induced labor from 9.5% to 29% in the last 3 decades. Circumstances requiring induction include gestational age of 41 weeks or more, hypertension, fetal growth disorder, gestational diabetes and others. There are different methods of induction, the choice of the best method depends on the bishop score, an estimate based on cervical related data like opening (cm), deletion (%) and other parameters, also the choice of induction method depends on the obstetric history of the mother. Bishop score less than 6, indicates an immature cervix, and therefore increases the chance of induction failure. The mechanism by which the catheter works includes a mechanical effect that causes the cervix to dilate, but in addition the direct stress on the inner surface of the cervix tissue and lower segment of the uterus indirectly causes local secretion of prostoglandins which help softening the cervix and may induce contractions. Inserting a single or double balloon catheter, is traditionally performed in a lithotomy position, and after inserting a speculum, disinfecting with polydine, identifying the external os of the cervix and then inserting the catheter, inflating the balloon with saline up to 30-80 ml while looking at the position of the balloon. Insertion of the catheter is typically speculum guided, but digital insertion has been reported to be faster, better tolerated and with similar insertion success and infections rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluate 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. Methods: A randomized trial. Participants are parous at term with unripe cervixes (Bishop Score ≤ 6) admitted for induction of labor. They will be randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position (1:1, 50 in each group). Primary outcomes are pain score [VAS] and time to birth. Secondary outcomes are procedure duration, maternal satisfaction, success and bishop score change.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 10, 2025
Est. primary completion date January 10, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Singelton parous women Term pregnancy Vertex position - Exclusion Criteria: Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
balloon catheter insertion approach for labor induction
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

Locations

Country Name City State
Israel Galil Medical Center Nahariya

Sponsors (1)

Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View Citation

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:CD001233. doi: 10.1002/14651858.CD001233.pub3. [Epub ahead of print] Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal pain sensation during the procedure VAS (visual analog scale) SCORE scale 0-10 0-better outcome 10-worse outcome during the procedure
Primary induction to delivery duration hours through study completion, an average of 1 year
Secondary catheter insertion duration minutes during the procedure
Secondary maternal satisfaction- questionnaire questionnaire including 5 questions about maternal preference for catheter insertion methods during one hour after the procedure
Secondary chorioamnionitis- fever during labor clinical diagnosis during labor up to 48 hours
See also
  Status Clinical Trial Phase
Recruiting NCT04949633 - Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening Phase 3
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Completed NCT00374621 - Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate N/A
Completed NCT02732522 - Comparison Between Vaginal and Sublingual Misoprostol 50 µg for Cervical Ripening Prior to Induction of Labor Phase 4
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT02975167 - Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor N/A
Recruiting NCT02738177 - Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation Phase 2
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00468520 - Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Recruiting NCT01156948 - Misoprostol For Nulliparous Women Before Hysteroscopy Phase 3
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Not yet recruiting NCT00815542 - Induction of Labor in Oligohydramnios Phase 3
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A