Dataset Information

Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR).

ABSTRACT:

Objective

To assess the impact of controlled cord traction on the incidence of postpartum haemorrhage and other characteristics of the third stage of labour in a high resource setting.

Design

Randomised controlled trial.

Setting

Five university hospital maternity units in France.

Participants

Women aged 18 or more with a singleton fetus at 35 or more weeks' gestation and planned vaginal delivery.

Interventions

Women were randomly assigned to management of the third stage of labour by controlled cord traction or standard placenta expulsion (awaiting spontaneous placental separation before facilitating expulsion). Women in both arms received prophylactic oxytocin just after birth.

Main outcome measure

Incidence of postpartum haemorrhage ≥ 500 mL as measured in a collector bag.

Results

The incidence of postpartum haemorrhage did not differ between the controlled cord traction arm (9.8%, 196/2005) and standard placenta expulsion arm (10.3%, 206/2008): relative risk 0.95 (95% confidence interval 0.79 to 1.15). The need for manual removal of the placenta was significantly less frequent in the controlled cord traction arm (4.2%, 85/2033) compared with the standard placenta expulsion arm (6.1%, 123/2024): relative risk 0.69, 0.53 to 0.90); as was third stage of labour of more than 15 minutes (4.5%, 91/2030 and 14.3%, 289/2020, respectively): relative risk 0.31, 0.25 to 0.39. Women in the controlled cord traction arm reported a significantly lower intensity of pain and discomfort during the third stage than those in the standard placenta expulsion arm. No uterine inversion occurred in either arm.

Conclusions

In a high resource setting, the use of controlled cord traction for the management of placenta expulsion had no significant effect on the incidence of postpartum haemorrhage and other markers of postpartum blood loss. Evidence to recommend routine controlled cord traction for the management of placenta expulsion to prevent postpartum haemorrhage is therefore lacking.

Trial registration

ClinicalTrials.gov NCT01044082.

SUBMITTER: Deneux-Tharaux C

PROVIDER: S-EPMC3610557 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPostpartum haemorrhage is a direct cause of maternal death worldwide and usually occurs during the third stage of labour. Most women receive some type of prophylactic management, which may include pharmacological or non-pharmacological interventions. The objective of this study was to summarize systematic reviews that assessed the effects of postpartum haemorrhage prophylactic management during the third stage of labour.MethodsWe applied the guidelines for conducting an overview of reviews from the Cochrane Handbook for Systematic Reviews of Interventions. We searched MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews to identify all relevant systematic reviews of randomized controlled trials of prophylactic management of postpartum haemorrhage in the third stage of labour compared with no treatment, placebo, or another management technique. Two review authors independently extracted data and assessed methodological quality using a measurement tool to assess reviews and quality of evidence using the Grades of Recommendation, Assessment, Development, and Evaluation for primary outcomes, summarizing results narratively.ResultsWe identified 29 systematic reviews: 18 Cochrane and 11 non-Cochrane. Cochrane systematic reviews were high quality, while the quality of non-Cochrane systematic reviews varied. The following techniques suggested effective, third-stage interventions to reduce the incidence of severe postpartum haemorrhage: active management of the third stage of labour compared to physiological management, active management compared to expectant management, administration of oxytocin compared to placebo, and use of tranexamic acid compared to placebo. The following third-stage management approaches reduced the need for blood transfusion: active management compared to physiological management, active management compared to expectant management, oral misoprostol compared to placebo, and tranexamic acid compared to placebo.ConclusionsNo effective prophylactic management techniques were identified for maternal mortality. Most methods of effective prophylactic management of postpartum haemorrhage were supported by evidence; however, they were limited to low- or moderate-quality evidence, and high-quality studies are therefore needed. Outcome measures of the included systematic reviews varied. It is recommended that outcome measures in preventive postpartum haemorrhage intervention trials align with the World Health Organization guidelines.Systematic review registrationPROSPERO: CRD42016049220 .

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Project description:BACKGROUND: Postpartum haemorrhage remains an important cause of maternal death despite treatment with conventional therapy. Uncontrolled studies and one randomised comparison with conventional oxytocics have reported dramatic effects with high-dose misoprostol, usually given rectally, for treatment of postpartum haemorrhage, but this has not been evaluated in a placebo-controlled trial. METHODS: The study was conducted at East London Hospital Complex, Tembisa and Chris Hani Baragwanath Hospitals, South Africa. Routine active management of the third stage of labour was practised. Women with more than usual postpartum bleeding thought to be related to inadequate uterine contraction were invited to participate, and to sign informed consent. All routine treatment was given from a special 'Postpartum Haemorrhage Trolley'. In addition, participants who consented were enrolled by drawing the next in a series of randomised treatment packs containing either misoprostol 5 x 200 microg or similar placebo, which were given 1 orally, 2 sublingually and 2 rectally. RESULTS: With misoprostol there was a trend to reduced blood loss >/=500 ml in 1 hour after enrolment measured in a flat plastic 'fracture bedpan', the primary outcome (6/117 vs 11/120, relative risk 0.56; 95% confidence interval 0.21 to 1.46). There was no difference in mean blood loss or haemoglobin level on day 1 after birth < 6 g/dl or blood transfusion. Side-effects were increased, namely shivering (63/116 vs 30/118; 2.14, 1.50 to 3.04) and pyrexia > 38.5 degrees C (11/114 vs 2/118; 5.69, 1.29 to 25). In the misoprostol group 3 women underwent hysterectomy of whom 1 died, and there were 2 further maternal deaths. CONCLUSIONS: Because of a lower than expected incidence of the primary outcome in the placebo group, the study was underpowered. We could not confirm the dramatic effect of misoprostol reported in several unblinded studies, but the results do not exclude a clinically important effect. Larger studies are needed to assess substantive outcomes and risks before misoprostol enters routine use.

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