Labor Induction After Cesarean Section: Outcome, Hormonal Trends

Induction of Labor Clinical Trial

Official title:

The Hormonal Milieu With Different Methods of Labour Induction: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244747
• Other study ID #: 0190-15-NHR
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2021
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria

• uncomplicated pregnancy
• 37-42 weeks of pregnancy
• singleton pregnancy
• cephalic presentation
• previous one low transverse cesarean section
• indicated induction of labour Exclusion Criteria
• fetal anomaly
• past uterine rupture
• previous preterm cesarean section
• multiple pregnancy
• polyhydramnios
• any contraindication for vaginal delivery or catheter balloon insertion

Related Conditions & MeSH terms

• Hormonal Changes
• Induction of Labor
• Previous Cesarean Section

Intervention

Device:
• induction of labor by breast stimulation

• induction of labor by catheter balloon

Locations

Country	Name	City	State
Israel	Galil Medical Center	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (11)

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. — View Citation

Huisman CMA, Ten Eikelder MLG, Mast K, Oude Rengerink K, Jozwiak M, van Dunné 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rahm VA, Hallgren A, Högberg 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. — View Citation

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. — View Citation

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. — View Citation

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:CD009792. doi: 10.1002/14651858.CD009792.pub3. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	changes in labour-associated maternal and fetal hormone levels	Maternal serum levels of: prostaglandin F2a (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
Primary	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	at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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