Platelet Indices and Recurrent Pregnancy Loss

NCT05190796 | Completed DMC

• 1 other identifier: 19819OBSGN26
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate relationship between platelet indices, red blood cell indices and recurrent pregnancy loss.

Conditions

Abortion, Recurrent

Outcome Measures

Primary Outcomes (3)

• Mean Platelet Volume

  a measure of the average size of the platelet, expressed in femtolitre (fL)

  1 day

• plateletcrit (PCT)

  a measure of total platelet mass, expressed in percentage (%)

  1 day

• Platelet Distribution Width (PDW)

  a measure that reflects variation of platelet size distribution, expressed in femtolitre (fL)

  1 day

Study Arms (2)

women with history of recurrent pregnancy loss.

100 women who had history of recurrent pregnancy loss.

Other: platelet indices

women without history of recurrent pregnancy loss.

50 women who had given birth at term (\>37 weeks of gestation) to healthy infants (control group)

Other: platelet indices

Interventions

platelet indices OTHER

One sample of 20 mL venous blood was drawn by standard phlebotomy from all of the participants. This sample was kept for the evaluation of hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), erythrocyte count, leukocyte count, platelet count, platelet distribution width (PDW), MPV and plateletcrit by means of an automated commercial counter (Coulter counter, Max Instruments Laboratory). After this venous blood sample was conveyed into a sodium citrate tube, it was transported in a temperature-controlled container and collected in plastic provettes (Falcon blue cap) containing 3 mL of 3.8% sodium citrate dihydrate and 136 mM glucosium. Then the samples were sent to the laboratory.

women with history of recurrent pregnancy loss.; women without history of recurrent pregnancy loss.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study included 150 subjects attending outpatient clinic of menoufia university hospital and were divided into two groups: * Group A: 100 women who had history of recurrent pregnancy loss. * Group B: 50 women who had given birth at term (\>37 weeks of gestation) to healthy infants (control group).

You may qualify if:

• patients with Recurrent miscarriage is defined as three or more consecutive pregnancy losses at or less than 20 weeks of gestation or with a fetal weight less than 500 grams

You may not qualify if:

• A woman who had experienced recurrent pregnancy loss due to uterine anomalies, diabetes mellitus and thyroid disease.
• Hypertensive women.
• Patients with coagulation defects.
• History of deep vein thrombosis or pulmonary thromboembolism.
• Use of medications affecting platelet functions such as aspirin, nonsteroidal anti-inflammatory drugs, oral contraceptives, hormonal treatments, anti-platelet, and anticoagulant drugs.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of obstetrics and gynecology

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)