RecruitingACTRN12622000039785

Management of secondary postpartum haemorrhage

Structured guidance in the management of secondary post-partum haemorrhage: A prospective cohort study involving women presenting to a single tertiary Womens' hospital.


Sponsor

Mercy Hospital for Women

Enrollment

120 participants

Start Date

Jul 1, 2021

Study Type

Observational

Conditions

Summary

The spectrum of illness in secondary PPH is vast. While some patients experience severe bleeding with haemodynamic instability, or even maternal death, more commonly the vaginal bleeding is less than with a primary PPH. However, the morbidity is still considerable, with many women requiring blood transfusion and surgical interventions such as hysterectomy (Hoveyda & MacKenzie, 2003). Breastfeeding, newborn bonding, and peripartum mental health are also impacted when prolonged inpatient care or repeated outpatient reviews are required. There are no randomised controlled trials or other high-quality research data to guide best management for women who present with a secondary PPH (Mavrides et al, 2016). With the exception of certain antibiotic regimes for postnatal endometritis, current management options for secondary PPH are, at best, based on Level 3 and Level 4 evidence. As such, most institutions and professional bodies do not have a specific policy or guideline to assist clinicians managing this relatively common complication, nor are there audit systems in place to assess safety and success of management. This prospective project aims to recruit women attending a single institution for the management of secondary PPH. This women will have baseline antenatal, intrapartum and postnatal data entered and then be invited to participate in a longitudinal study collecting survey-based data every 6months for 36months. A nested cohort study will arise from the patients managed surgically (group managed with traditional suction curette, compared to those managed hysteroscopically).


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Secondary postpartum haemorrhage (PPH) is vaginal bleeding that occurs more than 24 hours after delivery but within 12 weeks of giving birth. While less dramatic than bleeding immediately after birth, it can still be serious — sometimes requiring blood transfusions, surgery, or extended hospital stays — and it can deeply impact breastfeeding, newborn bonding, and mental health. Despite being a relatively common complication, there is very little high-quality research to guide how doctors should treat it. This prospective study at the Mercy Hospital for Women is collecting detailed data on women who present with secondary PPH, tracking their antenatal history, treatment, and recovery over 36 months. A nested comparison will also look at outcomes for women managed surgically with a traditional suction curettage versus hysteroscopic surgery. You may be eligible if you delivered at more than 20 weeks gestation, presented to the emergency department with secondary PPH between 24 hours and 12 weeks after birth, and are able to provide informed consent in English. This study does not test a new treatment — it is observational — but its findings will help build the evidence base needed to develop clear clinical guidelines for managing secondary PPH, ultimately improving care for future mothers.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients presenting 24hours - 12 weeks following birth (>20 weeks gestation) with abnormal vaginal bleeding or retained products of conception on ultrasound will be invited to participate in a longitu

Patients presenting 24hours - 12 weeks following birth (>20 weeks gestation) with abnormal vaginal bleeding or retained products of conception on ultrasound will be invited to participate in a longitudinal observational study. The clinician will enter data collected from existing medical records (without active input from participants), as well as prospectively collected data at time of the initial presentation (again without active input from the participant. Participants will then be required to complete a 10 minute online questionnaire on their health and fertility outcomes every 6 months for 36 months. Exposures of interest: 1. Surgical management of postpartum haemorrhage (PPH) 2. Hysteroscopic treatment of retained products of conception


Locations(1)

Mercy Hospital for Women - Heidelberg

VIC, Australia

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ACTRN12622000039785