Comparing Methods for Balloon Catheter Inserting: View Guided (Speculum) Versus Manual Guided at Cervical Examination
NCT ID: NCT05253690
Last Updated: 2022-04-01
Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-01-10
2025-01-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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speculum guided
view-guided approach using a speculum
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
manual guided
manual guided approach at cervical examination
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Dr. Maya Wolf
Director of fetal maternal unit
Principal Investigators
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Maya Wolf, MD
Role: STUDY_DIRECTOR
Galilee Medical Center
Locations
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Galil Medical Center
Nahariya, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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0150-21-NHR
Identifier Type: -
Identifier Source: org_study_id
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