Immediate Postpartum Hemorrhage Clinical Trial
Official title:
Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.
Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one
quarter of all maternal deaths worldwide. Its incidence estimates in the literature vary
widely, from 3% to 15% of deliveries. Uterotonics after birth are the only intervention that
has been shown to be effective for PPH prevention. Tranexamic acid (TXA), an antifibrinolytic
agent, has therefore been investigated as a potentially useful complement to uterotonics for
prevention because it has been proved to reduce blood loss in elective surgery, bleeding in
trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention
after cesarean (n=10) and vaginal (n=2) deliveries showed that women who had received TXA had
a significantly lesser amount of postpartum blood loss without any increase in severe
maternal adverse effect. However, overall, the quality of these trials was poor, and they
were not designed to test the effect of TXA on the reduction of PPH incidence, nor on the
incidence of rare but severe adverse effects. Large, adequately powered multicenter
randomized controlled trials are required before the widespread use of TXA for preventing PPH
can be recommended.
The investigators propose a multicentre randomised, double-blind, placebo-controlled trial,
with two parallel groups.
Individual information on the trial will be provided to women in late pregnancy during
prenatal visits. This information will be repeated when the women arrive in the delivery
room; the women then will confirm their participation and provide informed written consent
before delivery, when, in the opinion of the investigator, the woman is likely to have a
vaginal delivery with a minimum of 4 cm of cervix dilatation.
The intervention will be the intravenous administration of a 10-ml blinded ampoule of the
study drug (either 1g TXA or placebo according to the randomisation order), slowly (over
30-60 seconds), within 2 minutes after birth and prophylactic oxytocin administration, and
once the cord has been clamped.
All other aspects of management of the third stage will be identical in both arms:
- Routine prophylactic intravenous injection of 5 IU oxytocin at delivery of the anterior
shoulder or within 2 minutes after birth
- Placement of a graduated (100 mL graduation) collector bag just after birth, left in
place until the birth attendant judges that bleeding has stopped, and always at least
for 15 minutes. When a woman is included in the trial, a bag will be prepared and ready
to be put in place as soon as the baby is born and placed on the mother's belly; if
needed, a second staff person will be present to help in managing both the baby and the
bag. This will make it possible to collect and measure vaginal blood loss objectively
during the immediate postpartum.
- Manual removal of the placenta at 30 minutes after birth if not expelled in absence of
bleeding.
- Rapid suturing of the episiotomy, in accordance with good clinical practices
- Systematic use of uterotonic drugs after third stage of labor is not recommended.
- Controlled cord traction (CCT) will be left at the discretion of the practitioner.
If PPH occurs, standardised management will be provided according to the department's
protocol. In particular, the use of TXA for the treatment of PPH will be allowed and left at
the discretion of the practitioner according to the department's protocol.
The duration of the participation of each patient included in the trial will be from
inclusion through 3 months postpartum.
The planned total duration of the trial will be 34 months including 23 months of patient
inclusion
;
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