Effect of Doula in Nulliparas and Multiparas

Study Overview
=================
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.

Official Title
-----------------
Analgesic Efficacy of Doula in Nulliparous and Multiparous Women

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Behavioral: Doula
* Behavioral: Doula


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Doula for Nulliparous women | Behavioral: Doula<br>* Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery<br>|
| Active Comparator: 2<br>Doula for Multiparous women | Behavioral: Doula<br>* Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain intensity |  | From the beginning of regular contraction of uterus to the end of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Cesarean rate |  | During the whole period of laboring | 
| Overall feeling of satisfaction of analgesia |  | From the beginning of regular contraction of uterus to the end of the labor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Doula, Psychological care, Labor analgesia