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CompletedNCT00755092DINAMUpdated Feb 11, 2009

Effect of Doula in Nulliparas and Multiparas

An interventional study of Doula and Doula in Labor Pain, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to female participants aged 19 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-02-11.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
19 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Labor Pain

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Keywords

  • Doula
  • Psychological care
  • Labor analgesia
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 150 is above the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Healthy term parturients
  • Chinese
  • 19-45 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    1

    Doula for Nulliparous women

    Behavioral: Doula

  • Active comparator
    2

    Doula for Multiparous women

    Behavioral: Doula

Interventions

  • BehavioralDoula

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

  • BehavioralDoula

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

06

What researchers measure

Primary outcomes

  1. VAS pain intensity

    Time frame: From the beginning of regular contraction of uterus to the end of delivery

Secondary outcomes

  1. Ramsey sedative scale

    Time frame: From the beginning of regular contraction of uterus to the end of delivery

  2. Blood levels of corticosteroid

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

  3. Vital signs

    Time frame: From the beginning of regular contraction of uterus to the end of delivery

  4. Adverse events

    Time frame: From the beginning of regular contraction of uterus to the end of delivery

  5. Infant outcomes

    Time frame: The time of delivery to 1 h after delivery

  6. Cesarean rate

    Time frame: During the whole period of laboring

  7. Overall feeling of satisfaction of analgesia

    Time frame: From the beginning of regular contraction of uterus to the end of the labor

07

Study locations

1 site
  • Nanjing Medical University
    Nanjing, Jiangsu 210004, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00755092
Lead sponsor
Nanjing Medical University
First posted
Sep 18, 2008
Start date
Sep 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Feb 11, 2009

Study contacts

XiaoFeng Shen, MD
principal investigator · Nanjing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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