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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Michelle
Mayer
Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery
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Excessive bleeding after giving birth is a major complication of pregnancy globally. Bleeding after delivery is known as postpartum haemorrhage (PPH). PPH can result from a failure of the uterus (womb) to contract properly following birth. In the UK PPH occurs in 10% of births and additional treatments are needed to control the bleeding. This can include surgical removal of the womb, blood transfusion and prolonged hospital stay. Research has shown that women who experience PPH are less likely to want another child and 60% of those who have another pregnancy experience anxiety.
The current method of preventing PPH involves using a uterotonic drug to help the womb contract following delivery. The use of a uterotonic drug along with cutting of the umbilical cord and delivery of the placenta by controlled traction of the cord is known as Active Management of the Third Stage of Labour (AMTSL). AMTSL reduces the risk of PPH by 66%. Two thirds of pregnant women who experience PPH have no risk factors, so AMTSL is currently offered to all pregnant women. In the UK Syntometrine and Syntocinon are the two most commonly uterotonic drugs used in AMTSL. Both of these drugs mimic the natural hormone in the body that causes the uterus to contract. Syntometrine contains ergometrine which makes its affects last longer. However, this medication is associated with nausea, vomiting, and high blood pressure, and in some rare cases it has been linked to stroke which has been fatal. Syntometrine is known to be better at preventing moderate blood loss but not severe blood loss. Currently international guidelines recommend Syntocinon as the medicine of choice for AMTSL. At Southmead Hospital in Bristol a telephone survey of all consultant-lead maternity units in the UK was conducted to find out whether the guidelines for AMTSL were being followed. It was found that 71.4% of consultant-lead units still use Syntometrine as their first choice of uterotonic instead of Syntocinon as recommended. Many units reported that they had changed to Syntocinon following the publication of the guidelines but changed back to Syntometrine as they were concerned that their PPH rates had increased with Syntocinon. There is therefore a concern that women are being given a medicine (Syntometrine) that can cause potentially dangerous high blood pressure, and is contrary to national recommendations. A newer uterotonic called Carbetocin is offered for management of the third stage of labour after birth by caesarean section. This medication is not licenced for use in vaginal births. Studies have shown that Carbetocin is more effective at preventing bleeding following birth than Syntometrine. It also has fewer side effects than Syntometrine. Studies comparing Carbetocin and Syntocinon have shown that there is no significant difference in the risk of women bleeding heavily. Furthermore, Carbetocin reduces the need to have additional medication to aid the contraction of the womb. To date there have been no studies directly comparing Syntometrine, Syntocinon and Carbetocin for management of AMTSL in vaginal births. The aim of this study is to compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin in AMTSL in vaginal births.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30606246 protocol
You can take part if:
Current inclusion criteria as of 27/06/2018:
1. ≥18 years of age at time of delivery
2. Vaginal birth
3. Live, singleton pregnancy
4. >24 weeks
You may not be able to take part if:
Current exclusion criteria as of 27/06/2018:1. Significant antepartum haemorrhage (>50ml) or suspected or proven placenta abruption2. Maternal coagulation disorder3. Women who would decline blood products if required4. Known or suspected hypertensive disorders5. Peripheral, hepatic or cardiac disease6. Epilepsy7. Patients with an allergy or hypersensitivity to any of the active ingredients of the study drugs
Previous exclusion criteria:1. Significant antepartum haemorrhage (>50ml) or suspected or proven placenta abruption2. Maternal coagulation disorder3. Multiple pregnancy (twins or higher order)4. Intrauterine fetal death5. Patients who would decline blood products if required (i.e., Jehovah's Witnesses - clinicians may have a lower threshold for administering additional prophylactic uterotonic drugs to these patients)6. Known or suspected hypertensive disorders, including pre-eclampsia,pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled), and patients with hypertension in labour7. Patients with peripheral, hepatic or cardiac disease8. Patients with an allergy or hypersensitivity to any of the active ingredients in Carbetocin, Syntometrine or Syntocinon
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Michelle
Mayer
The study is sponsored by North Bristol NHS Trust and funded by Ferring Pharmaceuticals.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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