Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06179147 |
| Other study ID # |
ILKAYUNAL-DOKTORATEZI-2023 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Ege University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the research conducted within the scope of the doctoral thesis study is to
evaluate the effect of cervical traction applied at the end of the third stage of childbirth
on the oxytocin level and postpartum bleeding (hemoglobin level, estimated blood loss, and
amount of bleeding measured with a bleeding tracking bag). The study included 100 women in
the intervention group and 100 women in the control group, all of whom met the inclusion
criteria. Data were collected throughout the research via an Introduction Information Form,
Hemoglobin and Hematocrit Measurement, Calculation of Estimated Blood Loss (modified formula
of Gross (1983)), Oxytocin Measurement, and Measurement of bleeding amount with the Bleeding
Tracking Bag. Blood was drawn twice from all participating women. The hemoglobin levels of
the women were determined with these collected blood samples, and the change before and after
the application was identified. Additionally, the oxytocin hormone in the blood was also
examined. The change in oxytocin hormone levels before and after application, the difference
between groups, and the change within the women themselves were identified. Besides this, the
Bleeding Tracking Bag was placed under the women after the birth of the fetus and the amount
of bleeding was measured. The Bleeding Tracking Bag was placed under the woman after the
placenta was expelled, left for 15 minutes, and the amount of blood accumulated in the bag
was recorded in "ml". "Hemoglobin and Hematocrit measurement" was performed when the woman
was in the obstetrics ward, when cervical dilatation was 10 cm, and at the end of the 6th
hour after birth. Blood taken into the purple cap EDTA tube was delivered daily to an
external special laboratory. For determining the "oxytocin" level, 5 ml of blood was taken
into the gel blood collection tube when cervical dilatation was 10 cm. After placing the
bleeding tracking bag under the woman, cervical traction was applied to the intervention
group for 90 seconds. To determine the effect on the oxytocin level after 15 minutes (990
seconds) of applying traction, a second 5 ml blood was taken into the gel blood collection
tube. The blood taken was centrifuged by the researcher (PhD student) for 10 minutes and
separated into its serum. The separated serums were pipetted into a 1.5 ml Eppendorf tube and
stored at -80°C after labeling the tubes.
Description:
The research is a randomized controlled intervention study planned to evaluate the effect of
the cervical traction maneuver applied at the end of the third stage of labor on oxytocin
level and postpartum bleeding. The population of the research consisted of women who gave
birth vaginally in the hospital where the research will be conducted during the research
(1100 vaginal births between November 2022 and May 2023). realized). The sample of the study
consisted of 202 women who gave birth vaginally, where vacuum and forceps were not used, in a
training and research hospital obstetrics clinic in Turkey, who met the sample selection
criteria and agreed to participate in the study (Intervention group: 102 women; Control
group: 100 women). Two women in the intervention group were excluded from the study due to
the diagnosis of placenta acreata. The study was completed with 200 women. The smallest
sample size to be taken; In order to find the significant difference between the groups,
repeated measure analysis of variance (ANOVA) was determined by performing Power (Gpower)
analysis under the test. Because, in the study, three different variables will be measured in
order to determine the oxytocin level, hemoglobin and hematocrit level, and the amount of
bleeding with the bleeding follow-up bag. In the analysis, 196 cases were found sufficient by
taking α=0.05 and f=0.25 with 80% power. The sample size was taken as 200 cases against the
possibility of data loss.
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).
