comparison of maternal and neonatal outcomes between two delivery positions (lithotomy and hands& knees) in multiparous women in selected hospitals of Isfahan
Design
clinical trial with two intervention groups; with parallel groups; single blinded; randomized by sealed, opaque packets by random selection; on 72 multiparous women
Settings and conduct
In delivery room, After full dilatation of cervix, the participants will place in hands& knees or lithotomy position and maternal and neonatal outcome will be evaluated. The participants will not be blind. sampling is done in Asgarie hospital, Shaid Beheshti educational treatment search center, motahary hospital, hoiiy Zahra educational treatment search center
Participants/Inclusion and exclusion criteria
Inclusion criteria: ability of mother to place in the considered position; indication for normal vaginal birth
Exclusion criteria: contraindication for normal vaginal delivery; history of medical and psychological disorders
Intervention groups
First intervention group include multiparous women who locate in lithotomy position for birth.
Second intervention group include multiparous women who locate in hands&knees position for birth.
Main outcome variables
Duration of the second stage, active phase of the second stage and the third stage of delivery; severity of perceived pain by mother immediately after cutting cord and after placenta delivery; volume of lost blood in the third and fourth stages of delivery; shoulder dystocia; differences between hemoglobin at hospitalization time and 6 hours after birth; differences between hematocrit at hospitalization time and 6 hours after birth; severity of perineal tear; mother satisfaction; neonatal APGAR score; neonatal hospitalization need; neonatal resuscitation need; resuscitation level of neonate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091001002531N5
Registration date:2021-11-30, 1400/09/09
Registration timing:registered_while_recruiting
Last update:2021-11-30, 1400/09/09
Update count:0
Registration date
2021-11-30, 1400/09/09
Registrant information
Name
Tahmineh Dadkhahtehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7596
Email address
dadkhah-tehrani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of maternal and neonatal outcomes between two delivery positions of hands & knees and lithotomy in hospitalized multiparous women
Public title
Comparison of maternal and neonatal outcomes between two delivery positions
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of delivery in lithotomy position
normal physical and psychological condition during labor
term/single/alive fetus with cephalic presentation without anomalies
dilatation of cervix about 8 centimeter
fetal weight 2500-4000 gram
ability of mother to place in the considered position
having no sever obstetrics complications such as sever preeclampsia, placenta abruption
Exclusion criteria:
history of cesarean section or uterus surgery
contraindication for normal vaginal birth
use of epidural analgesia or other medication method of analgesia
history of medical and psychological disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate the participants to two group (lithotomy and hands&knees) randomly, the researcher will ask mothers to take a sealed opaque package out of 90 randomly. 45 packages contains questionnaires and checklists coded 1( related to lithotomy group) and 45 packages contains the same questionnaires and checklists coded 2( related to hands&knees group). It will be written code 1 or code 2 instead of lithotomy or hands&knees on the questionnaires and checklists in order to the data analyzer could be blinded. This process will continue until having at least 36 samples in both groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer is blinded because he/she dose not know the meaning of code 1 and 2 that is written on the questionnaires or checklists.
Placebo
Not used
Assignment
Parallel
Other design features
if the number of sealed package is considered 72( 36 lithotomy and 36 hands&knees) , after completion of 36 samples of one group , the remained samples of other group will be allocated to their groups without randomization and randomization concealment will not be conducted. So, 45 packages will be prepared and sampling will be conducted until having at least 36 samples in each group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Box 57, nursing and midwifery faculty, Isfahan university of medical sciences, Hezar-jerib street
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.086
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The duration of the second stage of delivery
Timepoint
From the full dilatation to the birth.
Method of measurement
The duration of time is measured by chronometer
2
Description
The duration of the active phase of the second stage
Timepoint
From the beginning of active pushing till the birth of newborn
Method of measurement
The duration of time is measured by a chronometer
3
Description
Duration of the third stage of delivery
Timepoint
From neonate birth to placenta delivery
Method of measurement
The duration of time is measured by a chronometer
4
Description
The score of severity of perceived pain in the second stage by mother immediately after cutting cord and after placenta delivery
Timepoint
Immediately after cutting cord and after placenta delivery
Method of measurement
The short form of Macgill pain questionnaire
5
Description
The volume of lost blood in the third and fourth stages of delivery
Timepoint
from birth of newborn till one hour after placenta delivery
Method of measurement
The volume of lost blood is measured by a researcher-made scaled reservoir rubber-sheet
6
Description
Shoulder dystocia
Timepoint
At birth time
Method of measurement
Observation
7
Description
Severity of perineal tear
Timepoint
After placenta delivery
Method of measurement
Observation
8
Description
Mother satisfaction
Timepoint
one hour after placenta delivery
Method of measurement
Satisfaction is measured by researcher-made quetionnaire
9
Description
Neonatal APGAR score
Timepoint
1 and 5 minutes after newborn birth
Method of measurement
Observation
10
Description
Neonatal need to hospitalization
Timepoint
After newborn birth
Method of measurement
Observation
11
Description
Neonatal need to resuscitation
Timepoint
After newborn birth
Method of measurement
Observation
Secondary outcomes
1
Description
difference between hemoglobin and hematocrit at hospitalization time and 6 hours after birth
Timepoint
hospitalization time and 6 hours after birth
Method of measurement
laboratory test of hemoglobin and hematocrit
2
Description
resuscitation level of neonate
Timepoint
after newborn birth
Method of measurement
observation
Intervention groups
1
Description
Intervention group1: After full dilatation of cervix, the participant is located in hands and knees position. The researcher records the precise times of full dilatation, spontaneous pushing, baby birth, placenta birth, and 1 hour after placenta birth is applying by chronometer. Probable shoulder dystocia and resuscitation of newborn with degree of resuscitation are recorded. After newborn birth, mother will return to supine position and a scaled reservoir pad is located beneath the mother’s buttocks and perineum until 1 hour after placenta birth to measure and record the volume of lost blood in 3th and 4th stages. Perineum is observed to assess the degree of tear. Severity of pain in the second stage is measured by Mcgill questionnaire through asking mother twice (immediately after cutting cord, at start of breastfeeding after placenta birth). APGAR score is determined using APGAR table 1 and 5 minute after birth. Satisfaction questionnaire is completed through asking mother 1 hour after placenta birth.The newborn is weighted using a digital scale during one hour after birth. Hemoglobin and hematocrit are recorded using the results of laboratory tests at hospitalization time and 6 hours after birth. Probable hospitalization of newborn and its cause is recorded. In all cases, delivery is done by main researcher and the measurements are done by the second researcher.
Category
Prevention
2
Description
Intervention group2: After full dilatation of cervix, the mother is located in lithotomy position on a 30 degree elevated bed. All measurements and data gatherings are conducted like hands and knees position group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Askaryeh hospital
Full name of responsible person
Tahmineh Dadkhahtehrani
Street address
Askaryeh hospital, askaryeh street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8199753966
Phone
+98 31 3225 0041
Email
tdtahmineh@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Beheshti education treatment search center
Full name of responsible person
Tahmineh Dadkhah Tehrani
Street address
Shahid Beheshti education treatment search center, Felezi bridge, Isfahan