Study Results
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Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2022-11-01
2023-06-30
Brief Summary
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Detailed Description
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Simple Random Numbers Table was used as the randomization method for sample selection. In this method; Randomly sorted algorithm was created at the maximum allowed percentage and 10% deviation in total 100 samples. In the algorithm, 100 sample (female) groups for both groups; Up to 200 randomly sorted as A and B. Intervention group: A, Control group: B. The sample taken according to the order in the list on the data collection days; It was accepted as group A or B (Piantdosi S, 2005; Pocock SJ, 1983; Rosenberger WF, 2002). The primary outcome measure of the RCT study was the difference between the cervical traction group and the control group.
Dependent variables of the research; Oxytocin level, hematocrit and hemoglobin value and amount of bleeding are the independent variables; It is the application of cervical traction.
Data were collected using the Introductory Information Form, the formula for Calculated Blood Loss (Gross's modified formula), measuring the oxytocin level and determining the amount of bleeding using Brass-V Drape (bleeding monitoring bag).
1. Introductory Information form:
The Introductory Information Form, created as a result of the literature review, consists of three sections: Socio-demographic Characteristics, Obstetric Characteristics and Characteristics of the Birth and Postpartum Period. There are a total of 25 questions in the Introductory Information Form (Erkaya R, 2019; Küçükoğlu S, 2019; Hamdy A, et al, 2019; Hamdy A, 2015; Gross JB, 1983).
2. Hemoglobin and Hematocrit Measurement:
Hemoglobin and hematocrit measurements were taken in all women in the intervention and control groups in the second stage of labor, when cervical dilatation was 10 cm and at the sixth hour after the birth of the fetus. This measurement was performed twice throughout the entire study. For measurement, 2 ml of whole blood was taken into a purple-capped EDTA tube from the vascular access (with branule) opened during the admission of the pregnant women to the delivery room, and the tube was mixed by slowly turning it upside down 5-6 times as soon as the blood was taken to prevent clots from forming in the tubes. Evaluation of hemoglobin and hematocrit was performed with the purchase of services from a private laboratory outside the hospital. The blood taken was delivered to the laboratory where the measurement would be made within seven hours.
3. Calculation of Estimated Blood Loss:
The amount of blood loss in women was calculated by the researcher using Gross (1983)'s modified formula (Estimated Blood Volume (EBV), estimated blood volume (mL) calculated as weight in kg x 85). For the formula, the Estimated Blood Volume (TKH) was determined first. After calculating THR with the formula "kgx85", Calculated Blood Loss (HKK) was obtained by multiplying the difference between THR and prenatal and postnatal hematocrit values by the average of prenatal and postnatal hematocrit values (Gross JB, 1983).
4. Oxytocin measurement:
When cervical dilatation is 10 cm and 990 sec after placenta separation. Blood was taken for measurement twice. The reason why cervical dilatation is evaluated when it is 10 cm; According to Roberts and Wolley (1996), the Ferguson reflex is generally activated when the presenting part of the fetus reaches at least +1 level (past the descending ischial spines). At this point, involuntary straining pressure occurs. Hamdy (2015) stated that the mechanism of action of the cervical traction maneuver can be explained by the Ferguson reflex. For this reason, oxytocin level was measured in the second phase before the intervention.
The second blood draw for oxytocin measurement is; It was performed at 990 sec (16 min. 30 sec) after delivery of the placenta. Oxytocin measurement was carried out by purchasing service from a private laboratory, as it was not a routine evaluation in the hospital where the research data would be collected. While taking blood, vascular access was used for pregnant women during their hospitalization in the delivery room. In case of giving parenteral fluid to the pregnant during labor, a separate vascular access was used for the blood to be taken from the pregnant.
5. Measurement of the amount of bleeding:
A Brass-V Drape (bleeding monitoring bag) was placed under the woman's hip to calculate the amount of bleeding after the placenta came out at the end of the third stage of labor. The bag was kept under the woman until oxytocin measurement (990 sec=16 min. 30 sec).
The research process was carried out in seven steps. The researcher did not make any application to the pregnant women during labor, the routine application and follow-up of the women were done by the midwives and physicians in the clinic. The researcher identified the women and took blood samples. Additionally, cervical traction was applied under the supervision of the responsible physician. The amount of bleeding was determined by the researcher using the Brass V Drape (Bleeding Bag). The women who underwent cervical traction formed the Intervention group (A), and the women who were routinely applied in the clinic without intervention constituted the Control group (B). Groups of women were determined with a table of random numbers.
In addition, in case of parenteral fluid administration to the woman during labor, a separate vascular access was used for the blood taken from the woman.
For intervention group (A):
* First step: An Introductory Information Form was applied to all women who agreed to participate in the study.
* Second step: In the second stage of labor, when cervical dilatation was 10 cm, blood was drawn from the vascular access opened during their admission to the delivery room to evaluate hemoglobin, hematocrit and oxytocin levels. This measurement was used to calculate blood loss as a prenatal measurement. The reason for oxytocin measurement is; According to Roberts and Wolley (1996), the Ferguson reflex is generally activated when the presenting part of the fetus reaches at least +1 level (past the descending ischial spines). At this point, involuntary straining pressure occurs. Hamdy (2015) stated that the mechanism of action of the maneuver he described can be explained by the Ferguson reflex. For this reason, the oxytocin level before the intervention was measured in the second phase.
* Third step: After the placenta came out (at the end of the third stage of labor), the researcher, paying attention to aseptic techniques, placed a Brass-V Drape (bleeding monitoring bag) under the woman's hip to calculate the amount of bleeding. The bag was kept under the woman until oxytocin measurement (990 sec=16 min. 30 sec).
* Fourth step: Following the birth of the placenta, women in the intervention group were subjected to continuous downward and backward traction on the anterior and posterior lips of the cervix with overpens for 90 seconds. Traction was performed until the cervix reached the vaginal introitus level. This process was applied by the researcher. During traction application with overpens, maneuvers were made in accordance with aseptic technique.
* Fifth step: The oxytocin level of the women in the intervention group was measured 990 seconds after the placenta came out. For oxytocin measurement, blood was taken from the vascular access opened during admission to the delivery room. Oxytocin level increases at the 15th minute after birth (Buckley S, 2015). The Bleeding Monitoring Bag was lifted from under the woman and the amount of bleeding was measured. Routine care of the fourth stage of labor especially includes monitoring and evaluation of PPH.
* Sixth step: Hemoglobin and hematocrit levels were checked 6 hours after the birth of the fetus. This measurement was used to calculate blood loss as a postpartum measurement.
* Seventh step: The amount of women's blood loss was calculated by the researcher using Gross (1983)'s modified formula (Estimated Blood Volume (EBV), estimated blood volume (mL) calculated as weight in kg x 85).
For the control group (B):
* First step: An Introductory Information Form was applied to all women who agreed to participate in the study.
* Second step: In the second stage of labor, when cervical dilatation was 10 cm, blood was taken from the vascular access opened during admission to the delivery room to evaluate hemoglobin, hematocrit and oxytocin levels. This measurement was used to calculate blood loss as a prenatal measurement. The reason for oxytocin measurement is; According to Roberts and Wolley (1996), the Ferguson reflex is generally activated when the presenting part of the fetus reaches at least +1 level (past the descending ischial spines). At this point, involuntary straining pressure occurs. Hamdy (2015) stated that the mechanism of action of the maneuver he described can be explained by the Ferguson reflex. For this reason, the oxytocin level before the intervention was measured in the second phase.
* Third step: After the placenta came out (at the end of the third stage of labor), the researcher, paying attention to aseptic techniques, placed a Brass-V Drape (bleeding monitoring bag) under the woman's hip to calculate the amount of bleeding after the placenta came out. The bag was kept under the woman until oxytocin measurement (990 sec=16 min. 30 sec).
* Fourth step: In this step, no intervention was made to the women in the control group.
* Fifth step: In this group, oxytocin level was measured 990 seconds after the placenta came out. For oxytocin measurement, blood was taken from the vascular access opened during admission to the delivery room. Oxytocin level increases at the 15th minute after birth (Buckley S, 2015). The Bleeding Monitoring Bag will be removed from under the woman and the amount of bleeding will be measured. Routine care of the fourth stage of labor especially includes monitoring and evaluation of PPH.
* Sixth step: Hemoglobin and hematocrit levels were checked 6 hours after the birth of the fetus. This measurement was used to calculate blood loss as a postpartum measurement.
* Seventh step: The amount of women's blood loss was calculated by the researcher using Gross (1983)'s modified formula (Estimated Blood Volume (EBV), estimated blood volume (mL) calculated as weight in kg x 85).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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cervical traction group (intervention group)
Immediately after the placenta was expelled, clamping with collum overpens and controlled traction visible through the vaginal introitus were applied to the women in the intervention group of the study. Traction was applied for 90 seconds.
cervical traction
Traction of the uterine cervix applied in the study; It is the process of pulling the anterior and posterior lips of the cervix towards the intraoitus, downwards and backwards for approximately 90 seconds using overpens. Traction is applied until the cervix reaches the level of vaginal introitus. It is a cost-effective, new, simple intervention with no reported adverse effects.
control group
No procedure was applied to the women in the control group after the placenta was expelled.
No interventions assigned to this group
Interventions
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cervical traction
Traction of the uterine cervix applied in the study; It is the process of pulling the anterior and posterior lips of the cervix towards the intraoitus, downwards and backwards for approximately 90 seconds using overpens. Traction is applied until the cervix reaches the level of vaginal introitus. It is a cost-effective, new, simple intervention with no reported adverse effects.
Eligibility Criteria
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Inclusion Criteria
* Non-risky pregnancies (pregnant women without systemic disease, without placental problems such as placenta previa, without fetal problems (eg: low birth weight, intrauterine growth retardation, macrosomia, presentation disorders), those without obstetric problems
* Pregnant women who do not have pre-existing maternal hemorrhagic disorders such as factor 8 or 9 deficiency or VonWillebrand disease,
* Pregnant women with hemoglobin level HB \<10 mg / dl and without previous C/S)
* Pregnant women with live fetuses
* Pregnant women at term (those who are older than the 37th week of pregnancy and less than the 42nd week of pregnancy)
* Those who can speak Turkish
* Pregnant women who gave consent to participate in the study were included.
Exclusion Criteria
* Pregnant women who have undergone induction of labor (induction with prostaglandin),
* It may occur in the second stage of birth; Pregnant women with pathological conditions such as shoulder insertion, bleeding and prolongation in the second stage, fetal distess, difficult delivery, vacuum and forceps application,
* It may occur in the third stage of birth; bleeding, placental retention, cavity control, third and fourth degree tear, etc. Pregnant women in situations such as
19 Years
40 Years
FEMALE
Yes
Sponsors
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The Scientific and Technological Research Council of Turkey
OTHER
Ege University
OTHER
Responsible Party
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İlkay Ünal
associate professor
Locations
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Ege University Faculty of Health Sciences
Karşiyaka, İ̇zmi̇r, Turkey (Türkiye)
Countries
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Other Identifiers
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ILKAYUNAL-DOKTORATEZI-2023
Identifier Type: -
Identifier Source: org_study_id