Does Induction Dosage in Latent Phase Affect Active Phase of Labor?

Induction of Labor Clinical Trial

Official title:

Does Induction Dosage in Latent Phase Affect Active Phase of Labor?A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742531
• Other study ID #: 50
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2021
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the need of oxytocin therapy in active phase of labor. there will be two groups treating with oxytocin in latent phase.One group will be treated with low dose oxytocin therapy and the other group will be treated with high dose oxytocin therapy. oxytocin treatment will be ceased at the beginning of the active phase of labor. the need of oxytocin treatment in active phase of labor will be compared between two groups.

Description:

Oxytocin treatment in active phase of labour is used with respect to clinicians preference and best approach has not been described. We want to investigate the effect of oxytocin treatment by using different regims in latent phase of labor when oxytocin treatment is ceased in active phase of labour. In our trial we discontinued oxytocin in active phase of labour and investigate which group needs oxytocin therapy due to inadequate uterine contractions and arrest of labor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 1, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Live fetus in cephalic presentation, sonographically estimated fetal weight less than 4200 g, undergoing induction of labor at 37-42 weeks of gestation, having indications of labor, no previous uterine surgery

Exclusion Criteria:

• malpresentation, placenta previa, previous uterine surgery, multiple gestation, active genital herpes, non-reassuring fetal heart rate pattern

Related Conditions & MeSH terms

• Induction of Labor
• Oxytocin

Intervention

Drug:
• oxytocin
one group will be treated with low dose oxytocin and the other group will be treated with high dose oxytocin for augmentation of labor induction.

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	need for oxytocin retreatment	need for oxytocin retreatment due to inadequate uterine contractions and labor arrest	an average of one year
Secondary	length of active phase	duration of acive phase of labor	an average of one year
Secondary	ratio of caesarean section	caesaraen section rate in total delivery	an average of one year
Secondary	total oxytocin dose	total amount of oxytocin treatment in latent and active phase of labor	an average of one year
Secondary	APGAR scores	neonatal 1 minute and 5-minute-APGAR scores	an average of one year