Investigating the Effect of the Family Physician Referral System on the Rate of Natural Delivery and Pregnancy Outcome and Satisfaction in Pregnant Women Referring to Comprehensive Health Service Centers: Randomized Controlled Trial
Determining the effect of the family physician referral system on the rate of natural delivery and pregnancy outcomes and satisfaction of pregnant women referring to comprehensive health service centers.
Design
The current study is a randomized controlled trial. 188 pregnant women in the first trimester of pregnancy were randomly selected from the health centers of and randomly assigned to two intervention and comparison groups.
Settings and conduct
The health centers of Astana Ashrafieh city
Participants/Inclusion and exclusion criteria
pregnant women with their first pregnancy, in the first trimester of pregnancy (between 6 and 12 weeks of pregnancy), who have a normal and low-risk pregnancy (Without obstetric and medical complications based on medical and obstetric history, with desired pregnancy) and no known mental illness, and willing to participate in the study until the end of pregnancy.
Intervention groups
Intervention group: Visits are made by midwives according to the instructions of the national pregnancy care program, except for special care cases, once in every first and second trimester, and three times in the third trimester (32-36-40 weeks). The family doctor will refer the woman. In addition, during pregnancy, childbirth preparation classes will be conducted exactly according to the educational protocol of pregnancy classes. When the labor pains start, the pregnant mother goes to the government hospital and gives birth with physiological birth techniques and labor analgesia. If there is any disturbance in the birth process, the cesarean section will be performed by the same gynecologist. And postpartum care will be done by comprehensive health service centers up to two months after delivery, as well as a referral to a gynecologist.
control group: care will be carried out according to the normal procedure.
Main outcome variables
Type of delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230711058749N1
Registration date:2023-07-18, 1402/04/27
Registration timing:prospective
Last update:2023-07-18, 1402/04/27
Update count:0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
zahra hamidi madani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3334 6489
Email address
zahra_hamidi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of the Family Physician Referral System on the Rate of Natural Delivery and Pregnancy Outcome and Satisfaction in Pregnant Women Referring to Comprehensive Health Service Centers: Randomized Controlled Trial
Public title
The Effect of the Family Physician Referral System on the rate of Natural Delivery and Pregnancy Outcome and Satisfaction in Pregnant Women Referring to Comprehensive Health Service Centers
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with their first pregnancy (with no history of childbirth or abortion)
In the first trimester of pregnancy (between 6 and 12 weeks of pregnancy)
Who has a normal and low-risk pregnancy (Without obstetric and medical complications based on medical and obstetric history, with desired pregnancy)
No known mental illness
Willing to participate in the study until the end of pregnancy.
Exclusion criteria:
Unwillingness to participate in the study
Not attending the training classes during the study
Age
From 9 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the method of random blocks will be used with a sequence of 4 and a ratio of 1:1
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan university of medical sciences
Street address
Guilan University of Medical Sciences' Headquarters - Parastar St. - Rasht
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.GUMS.REC.1402.125
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
(O00-O99)
ICD-10 code description
Pregnancy, childbirth and the puerperium
2
Description of health condition studied
Maternal care
ICD-10 code
O30-O48
ICD-10 code description
Maternal care related to the fetus and amniotic cavity and possible delivery problems
3
Description of health condition studied
Complications of labour and delivery
ICD-10 code
O60-O75
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
Type of delivery
Timepoint
Immediately after delivery
Method of measurement
Observation
Secondary outcomes
1
Description
Complications of pregnancy
Timepoint
Immediately after delivery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group:
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers and Kausar Hospital