NCT00755092

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

September 17, 2008

Last Update Submit

February 10, 2009

Conditions

Labor Pain

Keywords

DoulaPsychological careLabor analgesia

Outcome Measures

Primary Outcomes (1)

  • VAS pain intensity

    From the beginning of regular contraction of uterus to the end of delivery

Secondary Outcomes (7)

  • Ramsey sedative scale

    From the beginning of regular contraction of uterus to the end of delivery

  • Blood levels of corticosteroid

    10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery

  • Vital signs

    From the beginning of regular contraction of uterus to the end of delivery

  • Adverse events

    From the beginning of regular contraction of uterus to the end of delivery

  • Infant outcomes

    The time of delivery to 1 h after delivery

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Doula for Nulliparous women

Behavioral: Doula

2

ACTIVE COMPARATOR

Doula for Multiparous women

Behavioral: Doula

Interventions

DoulaBEHAVIORAL

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

1

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy term parturients
  • Chinese
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Medical University

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Doulas

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

CN(1)