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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| spontaneous labour | No Intervention | women in latent phase of spontaneous labour . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| induction of labor by breast stimulation | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at birth |
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Inclusion Criteria
Exclusion Criteria
women at term pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Maya Wolf, MD | Galilee Medical Center, Bar-Ilan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galil Medical Center | Nahariya | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23776853 | Background | 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. | |
| 14766445 | Background | 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. |
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| induction of labor by catheter balloon |
| Device |
|
|
| 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 | 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 | 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 | 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 | at 0, 3 and 6 hours post induction initiation or at controls during the latent phase |
| 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 | 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 | 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 | at birth |
| 29447299 | Background | 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. |
| 28599068 | Background | 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. |
| 22000899 | Background | 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. |
| 30723900 | Background | 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. |
| 25525601 | Background | 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. |
| 27521597 | Background | 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. |
| 24354335 | Background | 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. |
| 12421171 | Background | 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. |
| 31254523 | Background | 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. |
| 34231178 | Derived | 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. |