Labor PainDINAMNCT00755092
Effect of Doula in Nulliparas and Multiparas
A study testing Doula in people with Labor Pain, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Doula
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy term parturients
- Chinese
- 19-45 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Doula in Nulliparous and Multiparous Women
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.
- Conditions
- Labor Pain
- Being tested
- Doula
- Keywords
- Doula, Psychological care, Labor analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoulaBehavioural
Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery
DoulaBehavioural
Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Doula for Nulliparous women Receives: Behavioral: Doula |
| 2 | Active comparator | Doula for Multiparous women Receives: Behavioral: Doula |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain intensity
Measured: From the beginning of regular contraction of uterus to the end of delivery
Secondary outcomes (7)
Ramsey sedative scale
Measured: From the beginning of regular contraction of uterus to the end of delivery
Blood levels of corticosteroid
Measured: 10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery
Vital signs
Measured: From the beginning of regular contraction of uterus to the end of delivery
Adverse events
Measured: From the beginning of regular contraction of uterus to the end of delivery
Infant outcomes
Measured: The time of delivery to 1 h after delivery
Cesarean rate
Measured: During the whole period of laboring
Overall feeling of satisfaction of analgesia
Measured: From the beginning of regular contraction of uterus to the end of the labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755092
- Sponsor's protocol ID
- NMU-FY2008-416
- Other IDs
- NJFY-MZ08092
- Acronym
- DINAM
- Status last verified
- Feb 2009
- First submitted
- 17 Sep 2008
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Doula in Nulliparous and Multiparous Women
- ClinicalTrials.gov ID
- NCT00755092
- Acronym / sponsor ID
- DINAM / NMU-FY2008-416
- Conditions
- Labor Pain
- Keywords
- Doula, Psychological care, Labor analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: DoulaDoula for Nulliparous women |
| 2 | Active comparator | Behavioral: DoulaDoula for Multiparous women |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy term parturients
- Chinese
- 19-45 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoulaDoula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery | Behavioural | 1 |
| DoulaDoula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery | Behavioural | 2 |
Primary outcome
VAS pain intensity
Time frame: From the beginning of regular contraction of uterus to the end of delivery
7 secondary outcomes
Ramsey sedative scale
Time frame: From the beginning of regular contraction of uterus to the end of delivery
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
Vital signs
Time frame: From the beginning of regular contraction of uterus to the end of delivery
Adverse events
Time frame: From the beginning of regular contraction of uterus to the end of delivery
Infant outcomes
Time frame: The time of delivery to 1 h after delivery
Cesarean rate
Time frame: During the whole period of laboring
Overall feeling of satisfaction of analgesia
Time frame: From the beginning of regular contraction of uterus to the end of the labor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD principal investigator
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula in people with Labor Pain, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain intensity (time frame: From the beginning of regular contraction of uterus to the end of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2009.