Effect of Doula in Nulliparas and Multiparas

NCT ID: NCT00755092

Last Updated: 2009-02-11

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

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-01-31

Brief Summary

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Psychological care during labor is considered as an important supplemental procedure for alleviating delivering stress and pain. Although Doula has been recommending that should be given for parturients, its precise effect on nulliparous and multiparous women is still unknown. The investigators hypothesized that multiparas had experienced the process of labor, but the nulliparas were not, so Doula support would produce different effect on these two population.

Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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1

Doula for Nulliparous women

Group Type ACTIVE_COMPARATOR

Doula

Intervention Type BEHAVIORAL

Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery

2

Doula for Multiparous women

Group Type ACTIVE_COMPARATOR

Doula

Intervention Type BEHAVIORAL

Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery

Interventions

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Doula

Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery

Intervention Type BEHAVIORAL

Doula

Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy term parturients
* Chinese
* 19-45 years

Exclusion Criteria

* Organic dysfunction
* Participants younger than 19 years or older than 45 years
* Those who were not willing to or could not finish the whole study at any time
* Pregnancy-induced hypertension and diabetes mellitus
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Medical University

Principal Investigators

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XiaoFeng Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical University

Locations

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Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NJFY-MZ08092

Identifier Type: -

Identifier Source: secondary_id

NMU-FY2008-416

Identifier Type: -

Identifier Source: org_study_id

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