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IRCT20091001002531N5 IRCT 2021-11-30 Esfahan University of Medical Sciences Comparison of maternal and neonatal outcomes between two delivery positions Comparison of maternal and neonatal outcomes between two delivery positions of hands & knees and lithotomy in hospitalized multiparous women 2021-08-23 anticipated 72 Complete https://irct.ir/trial/57066 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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, 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 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. N/A . Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Tahmineh Dadkhah Tehrani
Faculty of Nursing & Midwifery, Isfahan University of Medical Science, hezarjerib street, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73465 +98 31 3792 7596 tdtahmineh@gmail.com Esfahan University of Medical Sciences scientific Tahmineh Dadkhah Tehrani
Faculty of Nursing & Midwifery, Isfahan University of Medical Sceince, hezarjerib street.
Isfahan Iran (Islamic Republic of) 81746-73465 +98 31 3792 7596 tdtahmineh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 no limit no limit Female 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 Prevention Prevention 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. 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 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. 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. 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. 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. 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. Shoulder dystocia. Timepoint: At birth time. Method of measurement: Observation. Severity of perineal tear. Timepoint: After placenta delivery. Method of measurement: Observation. Mother satisfaction. Timepoint: one hour after placenta delivery. Method of measurement: Satisfaction is measured by researcher-made quetionnaire. Neonatal APGAR score. Timepoint: 1 and 5 minutes after newborn birth. Method of measurement: Observation. Neonatal need to hospitalization. Timepoint: After newborn birth. Method of measurement: Observation. Neonatal need to resuscitation. Timepoint: After newborn birth. Method of measurement: Observation. 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. Resuscitation level of neonate. Timepoint: after newborn birth. Method of measurement: observation. Esfahan University of Medical Sciences Approved 2021-07-24 Ethics committee of Isfahan University of Medical Sciences Box 57, nursing and midwifery faculty, Isfahan university of medical sciences, Hezar-jerib street Isfehan Isfehan Iran (Islamic Republic of)