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

NCT ID: NCT03742531

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-15

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Oxytocin Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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synpitan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Eser

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmet eser

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Education and Research Hospital

Locations

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Zeynep Kamil Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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50

Identifier Type: -

Identifier Source: org_study_id

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