A single -blind controlled clinical trial will be conducted to assess the impact of the admission protocol on the labor process, interventions and maternal and new-born outcome in normal childbirth. Participants are low risk women and first time mothers. They randomly will be allocated in two intervention and control group based on table of random figure. Women in the intervention group will be admitted using protocol and in the control group will be admitted by midwives and doctors clinical judgment.The protocol implies a set of rules and regulations to identify the active phase and women's admission to labor at this time. The protocol of admission in labour is developed using evidence-based medicine resources. The protocol included important clues about onset of labour and will be used to identify the active phase in order to admit women in labour. In the control group, admission assessment will be only based on clinical judgment of midwives or doctors. The main outcome measures of this study are duration of active phase, duration of second stage of labor, interventions (oxytocin use, rate of episiotomy) postpartum hemorrhage, method of delivery, average time of admission to discharge, Apgar score, admission to neonatal ward or NICU and mother's childbirth satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112225051N1
Registration date:2017-08-27, 1396/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-27, 1396/06/05
Registrant information
Name
Farzaneh Pazandeh
Name of organization / entity
Shahid Beheshti Medical Univerisity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
pazandehf@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor of research Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using admission protocol in normal childbirth on labour process, interventions and maternal and infant outcome
Public title
The effect of using admission protocol in labour on labour process, interventions and maternal and infant outcome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: low risk pregnant women without know medical condition; maternal age: 18-35 years old; first pregnancy; singleton pregnancy; gestational age 38-42 weeks; vertex presentation; regular fetal heart rate; normal BMI (25-19); normal implantation of placenta; no CPD; no history of surgical treatment on uterus; no substance abuse (tobacco, alcohol, heroin, glass); Newborns have no known medical conditions; no congenital abnormalities; no IUGR and macrosomia.
Exclusion criterion: Vaginal bleeding more than normal and temperature up to 37/8 ° in admission
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Ethical commitee of Shahid Beheshti University of Medical Sciences
Street address
Medical Sciences University of Shahid Beheshti Nursing and Midwifery faculty of Shahid Behshti, Vali Asr intersection prayer in front of the Rajai Hospital Beheshti Department of Nursing and Midwifery
City
Tehran
Postal code
1985717443
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
SBMU2.REC.1394.160
Health conditions studied
1
Description of health condition studied
Relationship between use of protocol of admission process in labor and labor process, interventions and maternal and infant outcom
ICD-10 code
080
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Method of birth
Timepoint
After of delivery
Method of measurement
Observation and record in check list
Secondary outcomes
1
Description
Number of hospital visits
Timepoint
Site visits to admission
Method of measurement
Of enter to hospital to discharge or admission
2
Description
Number of vaginal examinations
Timepoint
During first stage of normal labour
Method of measurement
Observation, record in check list
3
Description
Use of continuous electronic fetal monitoring
Timepoint
During first stage of normal labor
Method of measurement
Observation, record in check list
4
Description
Medication and analgesics used during labor
Timepoint
During first and second stage of normal labor
Method of measurement
Observation, record in check list
5
Description
Use of fundal pressure
Timepoint
During second stage of normal labor
Method of measurement
Observation, record in check list
6
Description
Length of Postnatal Stay
Timepoint
During the fourth stage of labo
Method of measurement
Measurement by Digital chronometer, to record in check list
7
Description
Perineal and vaginal tears
Timepoint
After of delivery
Method of measurement
Observation, clinical examination, record in check list
8
Description
Unplanned out-of-Hospital Birth
Timepoint
After of delivery
Method of measurement
Observation, record in check list
9
Description
Apgar score
Timepoint
1 and 5 minute after of delivery
Method of measurement
Observation, record in check list
10
Description
Newborn admission to NICU
Timepoint
After of delivery
Method of measurement
Observation, record in check list
11
Description
Postpartum hemorrhage
Timepoint
After childbirth
Method of measurement
Measurement of HG and HCT level by blood sampling 24 h after childbirth
12
Description
Mother’s satisfaction of childbirth
Timepoint
Before discharging of hospital
Method of measurement
Macky satisfaction questionnaire
13
Description
Artificial rupture of membrane
Timepoint
In Latent phase before complete of dilatation
Method of measurement
Observation, record in check list
14
Description
Length of labour
Timepoint
admission time to delivery
Method of measurement
Measurement by Digital chronometer, to record in check list
15
Description
Length of first stage of labor
Timepoint
Since the onset of labor pains to full dilation of the cervix
Method of measurement
Clinical examination, Measurement by digital chronometer, record in check list
16
Description
Length of second stage of labor
Timepoint
Complete dilatation to full embryo excretion
Method of measurement
Clinical examination, Measurement by digital chronometer, record in check list
17
Description
Length of the third stage of labor
Timepoint
full embryo excretion to full placenta excretion
Method of measurement
Observation, clinical examination, record in check list
18
Description
Use of oxytocin during labor
Timepoint
During first and second stage
Method of measurement
Observation, record in check list
Intervention groups
1
Description
Intervention group: A protocol for admission in labour will be used for the intervention group. The protocol consisted of the following key information for diagnosing of active phase: a.Existence regular uterine contractions (3-5 contractions in 10 minutes takes 40-60- seconds) b. Dilation of cervix ≥ 4 cm c. Existence of rupture of membrane, or bloody show. d. Women who did not have these signs will be returned to their home. Women will be given awareness regarding danger signs. They will contact the hospital in the case of any problem. e. If there is a long distance problem or mother has intense anxiety, women will be stayed in a special place in hospital which has been designed for this purpose. The emotional support will be given to them.
Category
Other
2
Description
Control group: The admission of this group of participant women in labour will be solely based on the clinical judgment of midwives or doctors.