PREGNANCY & CHILDBIRTH
Trial Name: Immediate verus deferred cord clamping for preterm birth before 32 weeks gestation, a pilot randomised trial (Cord Pilot Trial)
Chief Investigator: Lelia Duley, The University of Nottingham
Trial Description: Preterm birth is the most important single determinant of adverse outcome in terms of survival, quality of life, psychosocial and emotional impact on the family, and costs for health services. In the UK one in every 70 babies is born before 32 weeks gestation (very preterm). For very preterm infants, the umbilican cord is usually clamped immediately at birth and the baby taken to a resuscitaire at the side of the room. Deferring cord clamping will allow blood flow between the placenta and baby to contine for a few minutes afer birth. The net flow is known as 'placental transfusion'. If cord clamping is defered, initial care and stabilisation of the baby will be at the bedside. There is promising evidence that deferring cord clamping at very preterm birth may be beneficial, but stronger evidence is needed about the effects on serious morbidity, mortality and disability-free survival.
This pilot trial is comparing cord clamping within 20 seconds with clamping after at least two minutes, for births before 32 weeks gestation. The aim is to assess the feasibility of conducting a large randomised trial in the UK. Recruitment was from March 2013 to February 2015. Overall 261 women/baby pairswere recruited at eight sites. Follow up for women is at one year, and for children at age two years (corrected for gestation at birth).
Contact: Lindsay Armstrong-Buisseret
Funding: NIHR Programme Grants for Applied Research
Status: Follow up
Publications: 2011-3; 2012-12; 2013-13; 2013-14; 2014-13; 2014-17; 2015-13; 2015-17; 2015-50
Further Information: Lindsay Armstrong-Buisseret (Trial Manager) firstname.lastname@example.org
Trial Name: Induction of labour at 39 weeks versus expectant management for nulliparous women over 35 years of age (35/39 Trial)
Chief Investigator: Jim Thornton, The University of Nottingham
Trial Description: In the UK, the average age at childbirth is increasing, with 20% of women now giving birth over 35 years of age. These women are at higher risk of perinatal death, and of pregnancy complications. Obstetric intervention increases with maternal age. Thirty eight percent of nulliparous women over 35 years give birth by Caesarean section, rising to 50% for women over 40 years.
This trial is comparing a policy of induction of labour at 39 weeks gestation for women aged over 35 years with a policy of awaiting spontaneous onset of labour. The primary outcome is Caesarean section. The study is also assessing the feasibility of conducting a larger trial to assess the comparative effects on perinatal mortality and serious neonatal morbidity. Estimated sample size was 630 women. Overall, 619 women participated. There were no significant differences between groups in the proportion of women who had caesarean section, or the proportion with short-term adverse maternal or neonatal outcome.
Contact: Jim Thornton
Funding: NIHR Research for Patient Benefit
Status: Main report in press
Further Information: email@example.com
Trial Name: Feasibility of conducting a randomised trial evaluating timing of cord clamping for preterm births in low and middle income countries (i-cord)
Chief Investigator: Lelia Duley, The Univeristy of Nottingham
Trial Description: An estimated 15 million babies are born before preterm (before 37 gestation weeks) each year, of whom more than 1 million die following complications of being born too early. Preterm birth is more common in low and middle income countries. Almost two thirds of preterm births occur in sub-Saharan Africa and South Asia. Inequalities in survival around the world are stark. For example, of infants born at 28 to 32 weeks gestation in high income countries 95% survive, compared with 30% in low income countries.
This study aims to assess feasibility of a large randomised trial comparing alternative policies for timing of cord clamping for births between 28 and 34 weeks gestation (or 1-2kg birthweight). A prospective audit of births at five hospitals in Uganda (2 sites), Kenya, India and Pakistan is assessing current practice for timing of cord clamping and for neonatal care in the delivery room, and the proportion of births which can be correctly indentified as being at this gestation. A seperate study in India is assessing the volume and duration of umbilical flow at preterm birth if the umbilical cord is not clamped immediately. Finally, potential barriers to recruitment in a randomised trial are being explored in a qualitative study in Uganda.
Contact: Lelia Duley
Funding: MRC/DFID/Welcome Trust Joint Global Health Trials scheme
Status: Analysis and reporting
Further Information: firstname.lastname@example.org
Trial Name: Do tests of placental function improve outcome for women with reduced fetal movements at 36 weeks gestation, or later? The REMIT-2 trial
Chief Investigator: Alexander Heazell, University of Manchester
Trial Description: In the UK, 1 in 220 babies are stillborn (born with no signs of life after 24 weeks of pregnancy). This is a higher proportion than in many other high income countries. Forty percent of babies who are stillborn die after 36 weeks of pregnancy and have no lethal structural abnormality. These deaths are tragedies for the families. If babies at a risk of stillbirth could be identified and delivered early, lives could be saved.
An assoication between the mother noticing reduced fetal movements and subsequent stillbirth has been documented for over 40 years. For women reporting reduced fetal movements at 36 weeks or later, standard care varies but usually includes assessment of the fetal heart rate with cardiotocography, and assessment of fetal growth and wellbeing by ultrasound scan and umbilical artery doppler. The aims of this trial are to assess whether using tests to measure placental function may improve pregnancy outcome, and if so to assess the feasibility of a large multicentre trial. The primary outcome is a composite measure which includes perinatal dealth, fetal growth restriction, umbilical artery PH <7.1 or admission to neontala intensive care unit for at least 48 hours. The sample size is 750 women.
Contact: Lindsay Armstrong-Buisseret
Funding: NIHR Clinican Scientist Fellowship
Status: Set up
Further Information: Lindsay Armstrong-Buisseret (Trial Manager) email@example.com