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Register:	IRCT
Last refreshed on:	22 February 2018
Main ID:	IRCT201408318801N9
Date of registration:	2016-08-15
Prospective Registration:	No
Primary sponsor:	Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Public title:	Development and evaluating a model of continuous midwifery care during pregnancy, labor and postpartum, an action research study
Scientific title:	Evaluation the effect of continuous midwifery care model during pregnancy, labor and postpartum on maternal and neonatal
Date of first enrolment:	2015-03-21
Target sample size:	200
Recruitment status:	Complete
URL:	http://en.irct.ir/trial/9290
Study type:	interventional
Study design:	Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.
Phase:	3

Countries of recruitment
Iran (Islamic Republic of)

Contacts

Name:	Masoumeh Simbar
Address:	Crossing Vali-Asr Neiayesh Tehran Iran (Islamic Republic of)
Telephone:	+98 21 8820 2519
Email:	msimbar@yahoo.com
Affiliation:	Shahid Beheshti University of Medical Sciences

Name:	Azam Bagheri
Address:	Nurse Street, Ravand High Way Kashan Iran (Islamic Republic of)
Telephone:	+98 31 5554 0021
Email:	asambagheri@yahoo.com
Affiliation:	Kashan University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria:
The Low risk pregnant women that:
- Their gestational age is under fourteen weeks
- They have not any diseases
- They have not previous high risk pregnancy
- They have not history for infertility
- They have not previous cesarean section
- They have not previous abdominal surgery
Exclusion criteria:
- Their pregnancy be high risk
- They have no desire to continue staying in the study
Exclusion criteria:

Age minimum: 18 years
Age maximum: 35 years
Gender: Female

Health Condition(s) or Problem(s) studied

pregnancy.
Supervision of normal pregnancy, unspecified

Supervision of normal pregnancy, unspecified

000-099

Intervention(s)

The intervention in case group includes: Hiring a responsible midwife for every pregnant woman. This midwife is a member of management team and provides direct care during prenatal, delivery and postpartum stages. If pregnant women need special care, the midwife will refer her to the specialist and will take feedback. Responsible midwife will continuously be available for pregnant women in different settings of home, health centers and hospital.

Intervention 1: The intervention in case group includes: Hiring a responsible midwife for every pregnant woman. This midwife is a member of management team and provides direct care during prenatal, delivery and postpartum stages. If pregnant women need special care, the midwife will refer her to the specialist and will take feedback. Responsible midwife will continuously be available for pregnant women in different settings of home, health centers and hospital. Intervention 2: The control group will receive routine care. In routine method, pregnant women refer to health center. There is not responsible midwife or continuous relationship with care provider. Most of women are under supervision of specialist no matter, they are high or low risk. Care providers change repeatedly during prenatal, delivery and postpartum stages. Care provider may be unknown for women.

The control group will receive routine care. In routine method, pregnant women refer to health center. There is not responsible midwife or continuous relationship with care provider. Most of women are under supervision of specialist no matter, they are high or low risk. Care providers change repeatedly during prenatal, delivery and postpartum stages. Care provider may be unknown for women.

Primary Outcome(s)

Breast feeding onset. Timepoint: at the end of intervention. Method of measurement: interview.

Hospitalization. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Duration of hospitalization. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Neonatal outcomes. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Maternal outcomes. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Number of sonography. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Duration of labor. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Fetal death before or after 24 weeks. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Gestational age at the termination. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Maternal satisfaction. Timepoint: 1 month after intervention. Method of measurement: Questionnaire.

Delivery type. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

5th minute Apgar score. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Analgesic and anesthesia. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Physiologic delivery. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Continuous pain after delivery. Timepoint: at the end of intervention. Method of measurement: interview.

Husband presence in visits. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Bleeding before delivery. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Number of visits in pregnancy. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Preterm neonate. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Episiotomy. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Expenditure. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and calculation.

Depression after delivery. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Induction. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

Perineal laceration. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Neonatal weight. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.

NICU hospitalization. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Vice chancellor for research, Shahid Beheshti University of Medical Sciences

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Kashan University of Medical Sciences

Results

Results available:
Date Posted:
Date Completed:
URL:

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