Induction of LaborNCT04244747
Labor Induction After Cesarean Section: Outcome, Hormonal Trends
A study testing induction of labor by breast stimulation and induction of labor by catheter balloon in people with Induction of Labor and Previous Cesarean Section, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Objectives- To compare changes in labour-associated maternal and fetal hormone levels during breast stimulation, balloon induction and spontaneous labour. To compare efficacy and safety of labour induction methods in women with previous caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor, Previous Cesarean Section, Hormonal Changes
- What is being tested?
- induction of labor by breast stimulation and induction of labor by catheter balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- uncomplicated pregnancy
- 37-42 weeks of pregnancy
- singleton pregnancy
- cephalic presentation
- previous one low transverse cesarean section
- indicated induction of labour
Who cannot join
- fetal anomaly
- past uterine rupture
- previous preterm cesarean section
- multiple pregnancy
- polyhydramnios
- any contraindication for vaginal delivery or catheter balloon insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hormonal Milieu With Different Methods of Labour Induction: a Prospective Randomized Controlled Trial
Objectives- To compare changes in labour-associated maternal and fetal hormone levels during breast stimulation, balloon induction and spontaneous labour. To compare efficacy and safety of labour induction methods in women with previous caesarean section.
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
Read the detailed description
Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol and cortisol levels were analyzed at 0, 3 and 6 hours post induction initiation, including the two groups catheter balloon and breast stimulation and controls in spontaneous labor. Fetal umbilical cord hormones were measured in the three mentioned above groups. Clinical outcomes were documented in the two induction groups.
- Being tested
- induction of labor by breast stimulation, induction of labor by catheter balloon
- Keywords
- labor induction,, previous caesarean section, hormonal levels, breast stimulation, intracervical balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction of labor by breast stimulationDevice
Also called breast stimulation
induction of labor by catheter balloonDevice
Also called catheter balloon
| Study group | Role | What they receive |
|---|---|---|
| induction of labour by breast stimulation | Active comparator | 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. Receives: Device: induction of labor by breast stimulation |
| induction of labour by catheter balloon | Active comparator | 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. Receives: Device: induction of labor by catheter balloon |
| spontaneous labour | No intervention | women in latent phase of spontaneous labour . |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in labour-associated maternal and fetal hormone levels
Maternal serum levels of:
oxytocin (pg/mL)
were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
Measured: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
changes in labour-associated maternal and fetal hormone levels
Maternal serum levels of:
prostaglandin F2α (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
Measured: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
changes in labour-associated maternal and fetal hormone levels
Maternal serum levels of:
prostaglandin E2 (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
Measured: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
changes in labour-associated maternal and fetal hormone levels
Maternal serum levels of:
prolactin (mclU/ml) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
Measured: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
changes in labour-associated maternal and fetal hormone levels
Maternal serum levels of:
estradiol (pmol/L) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
Measured: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
changes in labour-associated maternal and fetal hormone levels
Maternal serum levels of:
cortisol (μGr/dL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
Measured: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
changes in labour-associated maternal and fetal hormone levels
Maternal serum levels of:
testosterone (nmol/L) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
Measured: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Secondary outcomes (4)
To compare efficacy and safety of labour induction methods in women with previous caesarean section
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation): induction to delivery interval time in hours were measured after delivery in the two groups, medians were compared
Measured: at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation): fetal apgar score, medians were compared between the two induction groups
Measured: at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation):admission to neonatal intensive care unit rate, rates were measured after delivery and compared between the two induction groups
Measured: at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation):admission to neonatal intensive uterine rupture rates were compared in the two induction groups after delivery
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study startJan 2016
- Primary completionJul 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Maya Wolf, Western Galilee Hospital-Nahariya
- Investigators
- Maya Wolf, MD, Principal investigator, Galilee Medical Center, Bar-Ilan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244747
- Sponsor's protocol ID
- 0190-15-NHR
- Status last verified
- Apr 2021
- First submitted
- 19 Dec 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23776853Mears 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.
PubMed 14766445Takahata 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.
PubMed 29447299West 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.
PubMed 28599068Harper 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.
PubMed 22000899Huisman 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.
PubMed 30723900Singh 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.
PubMed 25525601Kehl 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.
PubMed 27521597Jozwiak 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.
PubMed 24354335Rahm 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.
PubMed 12421171Miller 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.
PubMed 31254523Wolf 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.
PubMed 34231178
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hormonal Milieu With Different Methods of Labour Induction: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04244747
- Acronym / sponsor ID
- 0190-15-NHR
- Keywords
- labor induction,, previous caesarean section, hormonal levels, breast stimulation, intracervical balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives- To compare changes in labour-associated maternal and fetal hormone levels during breast stimulation, balloon induction and spontaneous labour. To compare efficacy and safety of labour induction methods in women with previous caesarean section.
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
Detailed description
Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol and cortisol levels were analyzed at 0, 3 and 6 hours post induction initiation, including the two groups catheter balloon and breast stimulation and controls in spontaneous labor. Fetal umbilical cord hormones were measured in the three mentioned above groups. Clinical outcomes were documented in the two induction groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| induction of labour by breast stimulation | Active comparator | Device: induction of labor by breast stimulationwomen 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 labour by catheter balloon | Active comparator | Device: induction of labor by catheter balloonwomen 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. |
| spontaneous labour | No intervention | –women in latent phase of spontaneous labour . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- uncomplicated pregnancy
- 37-42 weeks of pregnancy
- singleton pregnancy
- cephalic presentation
- previous one low transverse cesarean section
Key exclusion criteria (6 listed)
- fetal anomaly
- past uterine rupture
- previous preterm cesarean section
- multiple pregnancy
- polyhydramnios
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| induction of labor by breast stimulationAlso: breast stimulation | Device | induction of labour by breast stimulation |
| induction of labor by catheter balloonAlso: catheter balloon | Device | induction of labour by catheter balloon |
Primary outcome
changes in labour-associated maternal and fetal hormone levels
Time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: oxytocin (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
changes in labour-associated maternal and fetal hormone levels
Time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: prostaglandin F2α (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
changes in labour-associated maternal and fetal hormone levels
Time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: prostaglandin E2 (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
changes in labour-associated maternal and fetal hormone levels
Time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: prolactin (mclU/ml) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
changes in labour-associated maternal and fetal hormone levels
Time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: estradiol (pmol/L) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
changes in labour-associated maternal and fetal hormone levels
Time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: cortisol (μGr/dL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
changes in labour-associated maternal and fetal hormone levels
Time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Maternal serum levels of: testosterone (nmol/L) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined
4 secondary outcomes
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time frame: at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time frame: at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time frame: at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time frame: at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 23776853Kota 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.
- Background: PubMed 14766445Mears 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.
- Background: PubMed 29447299Takahata 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.
- Background: PubMed 28599068West 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.
- Background: PubMed 22000899Harper 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.
- Background: PubMed 30723900Huisman 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.
- Background: PubMed 25525601Singh 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.
- Background: PubMed 27521597Kehl 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.
- Background: PubMed 24354335Jozwiak 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.
- Background: PubMed 12421171Rahm 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.
- Background: PubMed 31254523Miller 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.
- Derived from this study: PubMed 34231178Wolf 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.
- Individual participant dataSharing planned: No
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Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Wolf, MD principal investigator
Galilee Medical Center, Bar-Ilan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing induction of labor by breast stimulation and induction of labor by catheter balloon in people with Induction of Labor and Previous Cesarean Section, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in labour-associated maternal and fetal hormone levels (time frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244747, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.