Cervical Traction and Postpartum Hemorrhage

NCT06179147 | Completed DMC

• 1 other identifier: ILKAYUNAL-DOKTORATEZI-2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage; oxytocin; cervical traction

Outcome Measures

Primary Outcomes (2)

• postpartum hemorrhage (determined by hemoglobin and hematocrit level)

  Hemoglobin, hematocrit, calculated blood loss (Gross's modified formula) and the amount of blood accumulated in Brass V Drape and changes in these parameters of the women in the study before birth (when cervical dilatation was 10 cm) and after birth (6th hour after birth) has been examined.

  While the first blood from the women was cervical dilatation 10 cm, the second blood was taken at 6 hours postpartum.

• postpartum hemorrhage (Determined with Bleeding Tracking Bag)

  The amount of blood (ml) accumulated in the Brass V Drape within 15 minutes after the expulsion of the placenta after the third stage of labor.

  After the placenta was expelled, the bleeding monitoring bag was kept under the woman for 15 minutes.

Secondary Outcomes (1)

• Oxytocin level (pg/dL)

  The first blood was taken when the cervical dilation was 10 cm, and the second blood was taken after 15 minutes in the intervention group and after 16 minutes and 30 seconds in the control group.

Study Arms (2)

cervical traction group (intervention group)

EXPERIMENTAL

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.

Other: cervical traction

control group

NO INTERVENTION

No procedure was applied to the women in the control group after the placenta was expelled.

Interventions

cervical traction OTHER

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.

cervical traction group (intervention group)

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: women who gave birth vaginally were included
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18 and over who are not of advanced age
• 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.

You may not qualify if:

• It may occur in the first stage of labor; Pregnant women with pathological conditions such as non-progressive labor, abruption of the placenta, rupture, bleeding, cord prolapse, fetal distress, shoulder impingement,
• 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

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ege University Faculty of Health Sciences

Karşiyaka, İ̇zmi̇r, 35575, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: There are two groups: the cervical traction group (intervention group) and the control group.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: December 21, 2023
• Study Start: November 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)