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Completed

NCT Number: NCT00755092

Effect of Doula in Nulliparas and Multiparas

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Medical University

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doula

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Analgesic Efficacy of Doula in Nulliparous and Multiparous Women

Acronym: DINAM

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 18, 2008
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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