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Effect of Doula in Nulliparas and Multiparas

Analgesic Efficacy of Doula in Nulliparous and Multiparous Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00755092
Acronym
DINAM
Enrollment
150
Registered
2008-09-18
Start date
2008-09-30
Completion date
2009-01-31
Last updated
2009-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Doula, Psychological care, Labor analgesia

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.

Interventions

BEHAVIORALDoula

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

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
VAS pain intensityFrom the beginning of regular contraction of uterus to the end of delivery

Secondary

MeasureTime frame
Blood levels of corticosteroid10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery
Vital signsFrom the beginning of regular contraction of uterus to the end of delivery
Adverse eventsFrom the beginning of regular contraction of uterus to the end of delivery
Ramsey sedative scaleFrom the beginning of regular contraction of uterus to the end of delivery
Cesarean rateDuring the whole period of laboring
Overall feeling of satisfaction of analgesiaFrom the beginning of regular contraction of uterus to the end of the labor
Infant outcomesThe time of delivery to 1 h after delivery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026