Protocol summary

Summary
1) Objectives: Objectives include pregnancy outcomes, hemoglobin and hematocrit base levels prior to and during labor, mother's weight at an early stage and in 38 weeks of pregnancy, the frequency of preterm delivery, delivery characteristics (the length of active phase and second stage of labor, intense labor pain at 6-8 centimeters cervical dilatations and receiving oxytocin during labor), and the number of prenatal visits. (2) Design: This is a clinical trial in which participants are assigned into two groups of 4 and 6 selected through randomized permuted blocking. (3) Methods and materials: This study will be conducted on 120 women aged 11 to 19 years old who have the inclusion criteria, are willing to participate in the study, and refer to Ardebil's chosen Health-treatment centers. (4) Participants of the study will be 11 to 19-year-old pregnant women with gestational age of 20-24 weeks, having their first to third pregnancy, scored below 12 according to Edinburg's Depression Scale prior to intervention, showing no signs of physical and mental illnesses according to patients, willing to give birth in Tamin Ejtemai and Alavi hospitals of Ardebil, and have never participated in physiologic childbirth classes before. (5) Interventions: In the intervention group, 60 people will take part in 5 counseling sessions from 20 to 38 weeks of pregnancy while 60 participants of the control group will only receive the routine care of pregnancy. (6) The main outcome variables will be collected through self-administered pregnancy outcomes plus demographic questionnaires, VAS pain assessment tools, and partograph form.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201705146582N26
Registration date: 2017-07-24, 1396/05/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-24, 1396/05/02
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2017-05-14, 1396/02/24
Expected recruitment end date
2017-07-15, 1396/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counselling on pregnancy outcomes in pregnant teenage women: a randomized controlled clinical trial
Public title
The effect of counselling on pregnancy outcomes in pregnant teenage women
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria include 11 to 19-year-old pregnant women; with 20-24 weeks of gestational age; having their first, second, and third pregnancy; with contact numbers for future follow-up who have participated in at least 2 sessions of the total counselling sessions; have scored below 12 according to Edinburg's Depression Scale prior to intervention; and have shown willingness to give birth in Tamin Ejtemaie and Alavi hospitals of Ardebil. Exclusion criteria: Having any physical illnesses (e.g. epilepsy, heart disease, etc.); showing signs of mental illnesses according to patients; having history of hospitalization due to side effects from current pregnancy ( e.g. placental abruption; hemorrhage; preeclampsia; etc.); having history of preterm delivery and the presence of other risking factors associated to preterm delivery; diagnosis of fetal abnormalities; and previous participation in physiologic childbirth classes are among the exclusion criteria.
Age
From 11 years old to 19 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Shariaty street
City
Tabriz
Postal code
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.TBZMED.REC.1396.104

Health conditions studied

1

Description of health condition studied
Complications of pregnancy
ICD-10 code
(P01.-)
ICD-10 code description
Maternal complications of pregnancy

2

Description of health condition studied
Teenage pregnancy
ICD-10 code
P00.4
ICD-10 code description
Fetus and newborn affected by maternal nutritional disorders

Primary outcomes

1

Description
Delivery Characteristics (duration of active phase and second stage of labor)
Timepoint
During labor
Method of measurement
Using partograph and mother's admission forms

2

Description
Pain score
Timepoint
In 6-8 centimeters dilations
Method of measurement
Using VAS tools

3

Description
Receiving Oxytocin during labor
Timepoint
During labor
Method of measurement
Observation and assessment of mother' obstetrical chart

4

Description
Hematocrit and Hemoglobin
Timepoint
Pregnancy at early stage and during labor
Method of measurement
Cell catheter device

5

Description
Maternal weight gain during pregnancy
Timepoint
Pregnancy at early stage and during labor
Method of measurement
Adult weighing scale

6

Description
The frequency of preterm delivery
Timepoint
During labor / At the time of delivery
Method of measurement
Observation and assessment of mother' obstetrical chart

7

Description
Number of prenatal visits
Timepoint
End of pregnancy
Method of measurement
Assessment the mothers health chart

8

Description
The frequency of caesarean delivery /C-section
Timepoint
During labor / At the time of delivery
Method of measurement
Observation and assessment of mother' obstetrical chart

Secondary outcomes

1

Description
First and fifth minute Apgar score
Timepoint
Immediately and 5 minuets after birth
Method of measurement
Apgar score

2

Description
Anthropometric indicators
Timepoint
Immediately after birth
Method of measurement
Baby weighing scales, Fabric tape measure

3

Description
Postpartum Depression
Timepoint
Prior to and at the end of intervention
Method of measurement
Filling out depression questionnaire before and after intervention

4

Description
Breastfeeding
Timepoint
At the end of intervention
Method of measurement
Interview

5

Description
Family planning
Timepoint
At the end of intervention
Method of measurement
Interview

Intervention groups

1

Description
control group: Routine prenatal cares for pregnant women
Category
Other

2

Description
Intervention group: 5 sessions of group counselling will be conducted for 60 minutes in a room with comfortable and relaxing environment by the researcher. The minimum number of participants in each session will be 5 and the maximum will be 9 while the applied language for counselling will be in native. At the end of each session, individual counselling will be held for research participants upon their request. A contact number will be given to research participants in case they have any questions. The counselling content include training and consulting teenager's pregnancy symptoms, complications and introducing methods of prevention. After group introduction in the first session, participants are informed of the time and number of counselling sessions; they are further informed about pregnancy and its effective associative factors. In the second session, Participants are further counselled about the physiologic and hormonal changes during pregnancy, vaccination, and proper breathing techniques. Additional training and counselling regarding nutrition, personal hygiene, oral hygiene (mouth and dental cleanness) and pregnancy exercises along with proper breathing training will be given to them in the third session. In the fourth session, Participants are informed of the risks and complications involving teenage pregnancy (e.g. preterm labor, low birth weight, IUGR, etc), breastfeeding counselling as well as proper breathing techniques during labor, whereas in the fifth session, participants get familiar with symptoms of labor pain and its associated risks, childbirth type and family planning. Eventually in the final stage, private counselling sessions will be held for pregnant teenagers in the presence of their husbands which is based on their questions and problems. Control group: The control group will receive the routine prenatal cares.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health-care centers in Ardabil city and chosen hospitals
Full name of responsible person
Roya Shafagat
Street address
Health-care centers in Ardabil city and chosen hospitals
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, University Of Tabriz Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, ,
City
Tabriz
Grant name
Grant code / Reference number
IR.TBZMED.REC.1396.104
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, University Of Tabriz Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Master Of Sciences Of Midwifery
Full name of responsible person
Mahin Kamalifard
Position
lecturer, academic member Of Midwifery,Nursing &midwifery faculty, Tabriz University Of Medical Sci
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Shariaty st.
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 34796969
Email
kamalifardm@tbzmed.ac.ir
Web page address
nursing@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing & Midwifery, Tabriz University Of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Master Of Sciences Of Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Shariaty st.
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 414796969
Email
kamalifardm@tbzmed.ac.ir
Web page address
nursing@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Nursing & Midwifery, Tabriz University Of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Master Of Sciences Of Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Shariaty st
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
kamalifardm@tbzmed.ac.ir
Web page address
nursing@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...