Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth

NCT07884890 | Not Yet Recruiting

• 1 other identifier: WB-BLOODLOSS-2026
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

During a waterbirth, blood lost in the pool between the birth of the baby and the mother's exit from the water cannot be collected or measured. At the participating centers, blood loss is measured with a graduated collector bag that is positioned only after the woman leaves the pool, for the delivery of the placenta. The blood loss recorded after a waterbirth may therefore be lower than the true loss. The goal of this observational study, conducted in two Italian hospitals, is to learn whether measured blood loss underestimates true blood loss more after waterbirth than after birth on land. The main question it aims to answer is: Is the difference between blood loss calculated from the drop in hemoglobin and blood loss measured in the collector bag larger in women who give birth in water than in women who give birth on land without water immersion? Researchers will compare three groups of low-risk women with a singleton pregnancy at term: women who give birth in water, women who use water immersion during labor but give birth out of water, and women who do not use water immersion. No intervention is assigned by the study: each woman is classified according to what actually happened during her labor and birth. Data are taken from the clinical record and include hemoglobin at admission in labor and after birth, measured blood loss, and the timing of events in the pool and during the third stage of labor.

Conditions

Postpartum Hemorrhage; Waterbirth

Keywords

water immersion; calculated blood loss; quantitative blood loss; third stage of labor

Outcome Measures

Primary Outcomes (1)

• Difference between calculated and measured blood loss

  Individual difference, in mL, between calculated blood loss and blood loss measured in the graduated collector bag. Calculated blood loss = maternal weight (kg) x 85 x (hemoglobin at admission in labor - postpartum hemoglobin) / hemoglobin at admission in labor. The difference is compared between Group A (waterbirth) and Group C (land birth without water immersion).

  From admission in labor to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)

Secondary Outcomes (6)

• Peripartum hemoglobin drop

  From admission in labor to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)

• Postpartum hemorrhage of 500 mL or more, by each assessment method

  From birth to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)

• Postpartum hemorrhage of 1000 mL or more, by each assessment method

  From birth to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)

• Red blood cell transfusion

  From birth to hospital discharge, an average of 3 days

• Intravenous iron administration

  From birth to hospital discharge, an average of 3 days

Study Arms (3)

Group A: Waterbirth

Women who gave birth in water. All consecutive waterbirths in the study period are included. The graduated collector bag is positioned after the woman leaves the pool, for the delivery of the placenta. No intervention is assigned by the study.

Other: Water immersion during labor and birth

Group B: Water Immersion in Labor, Birth out of Water

Women who used water immersion during labor and gave birth out of water. All consecutive women in the study period are included, and the reason for leaving the pool is recorded. No intervention is assigned by the study.

Other: Water immersion during labor and birth

Group C: Land Birth Without Water Immersion

Women with no water immersion at any time in labor and a spontaneous vaginal birth on land. For each waterbirth, the next three consecutive eligible births of the same parity category within 30 days are selected from the delivery ward register. No intervention is assigned by the study.

Interventions

Water immersion during labor and birth OTHER

Exposure of interest, not assigned by the study. Women choose whether to use the birthing pool as part of routine care: immersion in warm water during labor only (Group B) or during labor and birth of the baby (Group A). The study only observes and records the exposure and its timing.

Group A: Waterbirth; Group B: Water Immersion in Labor, Birth out of Water

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Low-risk women with a singleton pregnancy at term giving birth at two Italian maternity units (Caserta and Avellino) that offer water immersion in labor and waterbirth. Women are identified consecutively from the delivery ward register and classified according to their actual use of water immersion.

You may qualify if:

• Singleton pregnancy
• Cephalic presentation
• Gestational age from 37 weeks 0 days to 41 weeks 6 days
• Low-risk pregnancy, eligible for water immersion according to the protocol of the center
• Hemoglobin measured at admission in labor
• Vaginal birth; for Group C, spontaneous vaginal birth with no water immersion at any time in labor

You may not qualify if:

• Blood transfusion before the postpartum blood sample
• Known coagulopathy
• Cesarean delivery
• Operative vaginal delivery (Group C)

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Moscati (Avellino): collaborator

Study Sites (2)

Azienda Ospedaliera San Giuseppe Moscati - UOC di Ginecologia e Ostetricia

Avellino, Campania, Italy

Location

University of Campania Luigi Vanvitelli

Caserta, Campania, Italy

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Parturition

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Marco La Verde, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco La Verde, MD

CONTACT

+390815665600; marco.laverde@unicampania.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)