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

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

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.

Study Overview

• Status: Completed
• Conditions: Oxytocin; Induction of Labor
• Intervention / Treatment: Drug: oxytocin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • zeynep kamil education and research hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: low dose group; oxytocin therapy starting with 2mU/min increased by 2 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.	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.; Other Names: synpitan
ACTIVE_COMPARATOR: high dose group; oxytocin therapy starting with 4mU/min increased by 4 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.	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.; Other Names: synpitan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for oxytocin retreatment	need for oxytocin retreatment due to inadequate uterine contractions and labor arrest	an average of one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of active phase	duration of acive phase of labor	an average of one year
ratio of caesarean section	caesaraen section rate in total delivery	an average of one year
total oxytocin dose	total amount of oxytocin treatment in latent and active phase of labor	an average of one year
APGAR scores	neonatal 1 minute and 5-minute-APGAR scores	an average of one year

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Investigators: Principal Investigator: ahmet eser, zeynep kamil education and research hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2018
• Primary Completion (ACTUAL): June 15, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (ACTUAL): November 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes