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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| speculum guided | Active Comparator | view-guided approach using a speculum |
|
| manual guided | Experimental | manual guided approach at cervical examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| catheter insertion duration | minutes | during the procedure |
| maternal satisfaction- questionnaire | questionnaire including 5 questions about maternal preference for catheter insertion methods |
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Inclusion Criteria:
Singelton parous women Term pregnancy Vertex position
-
Exclusion Criteria:
Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly
Pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Wolf, MD | Contact | 972-50-7887800 | mayaw@gmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Maya Wolf, MD | Galilee Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galil Medical Center | Recruiting | Nahariya | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21615714 | Background | 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. | |
| 33278290 | 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. |
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| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Randomized control trial
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The obstetrician evaluating labor progress is blinded for type of intervention
| during one hour after the procedure |
| chorioamnionitis- fever during labor | clinical diagnosis | during labor up to 48 hours |
| 32471369 | 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. |
| 31619189 | 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. |
| 31623014 | 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. |
| 36972835 | Derived | 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. |