Labor Induction After Cesarean Section: Outcome, Hormonal Trends
NCT ID: NCT04244747
Last Updated: 2021-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2016-01-31
2020-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Design- Participants were randomized to undergo induction of labour by breast stimulation or intracervical balloon compared to spontaneous labour (controls).
Setting- A single tertiary hospital Population- women at term, with previous caesarean section
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Breast Stimulation vs. Low Dose Oxytocin Augmentation for Labor Induction
NCT05510310
Induction of Women With Fear of Labor
NCT01424059
The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.
NCT02768142
Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section
NCT05246761
Castror Oil for Labor Induction in Women With Previous Cesarean Section
NCT03958981
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
induction of labour by breast stimulation
women at term with previous cesarean section and an indication to induce labor. In order to induce labour by breast stimulation, an electrical pump was used. The cup was alternated between the nipples every 15 minutes, with a pause of 15 minutes after each 30 minutes, with a total induction time of 6 hours.
induction of labor by breast stimulation
induction of labour by catheter balloon
women at term with previous cesarean section and an indication to induce labor. In the catheter balloon group, a 16-F Foley catheter was inserted into the cervical canal and inflated with 60 cc sterile saline solution and was kept in place for 12 hours.
induction of labor by catheter balloon
spontaneous labour
women in latent phase of spontaneous labour .
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
induction of labor by breast stimulation
induction of labor by catheter balloon
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 37-42 weeks of pregnancy
* singleton pregnancy
* cephalic presentation
* previous one low transverse cesarean section
* indicated induction of labour
Exclusion Criteria
* past uterine rupture
* previous preterm cesarean section
* multiple pregnancy
* polyhydramnios
* any contraindication for vaginal delivery or catheter balloon insertion
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Maya Wolf
Head of fetal-maternal unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maya Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
Galilee Medical Center, Bar-Ilan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Galil Medical Center
Nahariya, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kota SK, Gayatri K, Jammula S, Kota SK, Krishna SV, Meher LK, Modi KD. Endocrinology of parturition. Indian J Endocrinol Metab. 2013 Jan;17(1):50-9. doi: 10.4103/2230-8210.107841.
Mears K, McAuliffe F, Grimes H, Morrison JJ. Fetal cortisol in relation to labour, intrapartum events and mode of delivery. J Obstet Gynaecol. 2004 Feb;24(2):129-32. doi: 10.1080/01443610410001645389.
Takahata K, Horiuchi S, Tadokoro Y, Shuo T, Sawano E, Shinohara K. Effects of breast stimulation for spontaneous onset of labor on salivary oxytocin levels in low-risk pregnant women: A feasibility study. PLoS One. 2018 Feb 15;13(2):e0192757. doi: 10.1371/journal.pone.0192757. eCollection 2018.
West HM, Jozwiak M, Dodd JM. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017 Jun 9;6(6):CD009792. doi: 10.1002/14651858.CD009792.pub3.
Harper LM, Cahill AG, Boslaugh S, Odibo AO, Stamilio DM, Roehl KA, Macones GA. Association of induction of labor and uterine rupture in women attempting vaginal birth after cesarean: a survival analysis. Am J Obstet Gynecol. 2012 Jan;206(1):51.e1-5. doi: 10.1016/j.ajog.2011.09.022. Epub 2011 Sep 24.
Huisman CMA, Ten Eikelder MLG, Mast K, Oude Rengerink K, Jozwiak M, van Dunne F, Duvekot JJ, van Eyck J, Gaugler-Senden I, de Groot CJM, Franssen MTM, van Gemund N, Langenveld J, de Leeuw JW, Oude Lohuis EJ, Oudijk MA, Papatsonis D, van Pampus M, Porath M, Rombout-de Weerd S, van Roosmalen JJ, van der Salm PCM, Scheepers HCJ, Sikkema MJ, Sporken J, Stigter RH, van Wijngaarden WJ, Woiski M, Mol BWJ, Bloemenkamp KWM; PROBAAT-S project group. Balloon catheter for induction of labor in women with one previous cesarean and an unfavorable cervix. Acta Obstet Gynecol Scand. 2019 Jul;98(7):920-928. doi: 10.1111/aogs.13558. Epub 2019 Mar 7.
Singh N, Tripathi R, Mala YM, Yedla N. Breast stimulation in low-risk primigravidas at term: does it aid in spontaneous onset of labour and vaginal delivery? A pilot study. Biomed Res Int. 2014;2014:695037. doi: 10.1155/2014/695037. Epub 2014 Nov 27.
Kehl S, Weiss C, Rath W. Balloon catheters for induction of labor at term after previous cesarean section: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:44-50. doi: 10.1016/j.ejogrb.2016.07.505. Epub 2016 Aug 3.
Jozwiak M, van de Lest HA, Burger NB, Dijksterhuis MG, De Leeuw JW. Cervical ripening with Foley catheter for induction of labor after cesarean section: a cohort study. Acta Obstet Gynecol Scand. 2014 Mar;93(3):296-301. doi: 10.1111/aogs.12320. Epub 2014 Jan 13.
Rahm VA, Hallgren A, Hogberg H, Hurtig I, Odlind V. Plasma oxytocin levels in women during labor with or without epidural analgesia: a prospective study. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1033-9. doi: 10.1034/j.1600-0412.2002.811107.x.
Miller N, Asali AA, Agassi-Zaitler M, Neumark E, Eisenberg MM, Hadi E, Elbaz M, Pasternak Y, Fishman A, Biron-Shental T. Physiological and psychological stress responses to labor and delivery as expressed by salivary cortisol: a prospective study. Am J Obstet Gynecol. 2019 Oct;221(4):351.e1-351.e7. doi: 10.1016/j.ajog.2019.06.045. Epub 2019 Jun 27.
Wolf MF, Sgayer I, Asslan A, Palzur E, Shnaider O, Bornstein J. The Hormonal Milieu by Different Labor Induction Methods in Women with Previous Cesarean Section: a Prospective Randomized Controlled Trial. Reprod Sci. 2021 Dec;28(12):3562-3570. doi: 10.1007/s43032-021-00667-3. Epub 2021 Jul 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0190-15-NHR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.