Trial no.:
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PACTR202001882345033 |
Date of Approval:
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13/01/2020 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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The effect of cranial uterine traction on the incidence of postpartum hemorrhage: A randomized clinical trial |
Official scientific title |
The effect of cranial uterine traction on the incidence of postpartum hemorrhage: A randomized clinical trial |
Brief summary describing the background
and objectives of the trial
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Globally, between one-quarter to one-third of maternal deaths have been reported to be caused by postpartum hemorrhage (PPH)1-3, with prevalence rates varying widely, ranging from 7.2% in Oceania to 25.7% in Africa in a systematic review of studies from 1997–20092; however, a global incidence of 2% was reported by WHO in 20121. PPH is also a significant contributor to severe long-term morbidity4-6. Uterine atony is the most significant cause of PPH; however, other important contributing factors include trauma (lacerations or ruptured uterus), retained placenta, and coagulation disorders. Pre-existing anemia can also aggravate the clinical consequences of PPH7.
One of the most prominent breakthroughs in the prevention of PPH was active management of the third stage of labor (AMTSL). AMTSL, first described in 1962, gave the three main components as prophylactic uterotonic drug administration, early cord clamping and cutting, and controlled cord traction8. In 2003, the International Confederation of Midwives and the International Federation of Gynecology and Obstetrics (FIGO) released their first statement on AMTSL9. Thereafter, AMTSL was considered the gold standard intervention for reducing the incidence of PPH3, 10. In the last two decades, much research has been conducted to improve measures to prevent PPH, which culminated in 2012 with the addition of misoprostol to the armamentarium for its prevention1.
Additional interventions may help further reduce the incidence of PPH and its associated maternal mortality. We innovated a new technique that can be considered a modification to Amr's maneuver11 for the prevention of PPH. This technique avoids the possibility of increasing uterine prolapse that may result from routine uterine massage or Amr's maneuver.
The aim of the present randomized controlled trial is to test the hypothesis that using Khalid's maneuver in conjunction with AMTSL would decrease the incidence of PPH after vaginal delivery more than that achieve |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Pregnancy and Childbirth |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Prevention |
Anticipated trial start date |
15/01/2020 |
Actual trial start date |
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Anticipated date of last follow up |
15/06/2020 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
1010 |
Actual target sample size (number of participants) |
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Recruitment status |
Completed |
Publication URL |
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