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An RCT Study Between WHO and RCOG Based Practices (WHO and RCOG)

3. august 2026 opdateret af: Sana Nadeem Qasir

A Randomized Controlled Trial Comparing WHO- and RCOG-Based Practices for Routine Iron Supplementation in Postpartum Women With Normal Hemoglobin Level

Investigator is doing this study to understand the best way to give iron supplements to mothers after delivery who already have a normal blood level (hemoglobin). Some guidelines recommend one approach, while others recommend a different approach. In this study, investigator will compare these two methods to see which one is more helpful and suitable for mothers. Participants participation will help us improve care for women after childbirth in the future. Taking part is participants choice, and all participants information will be kept private.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

Postpartum women may be at risk of developing iron deficiency and postpartum anemia due to blood loss during childbirth. Iron supplementation after delivery is commonly used to prevent anemia; however, the benefit of routine iron supplementation in postpartum women who already have normal hemoglobin levels remains an area of discussion.

This randomized controlled trial aims to compare routine iron supplementation with no iron supplementation in postpartum women with normal hemoglobin levels.

Eligible postpartum women with normal hemoglobin levels will be randomly allocated into two groups. The intervention group will receive Polymalt F (iron polymaltose complex with folic acid), one tablet daily for 6 weeks postpartum. The control group will not receive routine iron supplementation during the study period and will receive standard postpartum care.

Participants will be followed up at 6 weeks postpartum. Maternal outcomes will be assessed, including hemoglobin level, development of postpartum anemia, fatigue level,compliance with supplementation, and any reported side effects among participants receiving iron.

The primary outcome of this study is to determine whether routine iron supplementation prevents postpartum anemia in women with normal hemoglobin levels. The findings may help provide evidence regarding the need for routine iron supplementation after childbirth and improve postpartum care practices.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Sana Nadeem Qasir, MBBs,trainee FCPS
  • Telefonnummer: +925812920063 +923209801699
  • E-mail: nadeemsana77@gmail.com

Undersøgelse Kontakt Backup

  • Navn: Prof.Dr.SARAH Jamil khan, consultant

Studiesteder

    • Gilgitbaltistan
      • Chilas, Gilgitbaltistan, Pakistan, 14100
        • Regional headquarters hospital chilas

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Women aged 18-40 years
  • Single Term Vaginal delivery
  • Hemoglobin ≥10.5 g/dL at 24hour of delivery
  • Willing for follow-up

Exclusion Criteria:

  • Postpartum hemorrhage
  • Hemoglobin <10.5 g/dL
  • Blood transfusion received
  • Known hematological disease
  • Chronic liver or kidney disease
  • Cesarian section

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ARM1 ,Intervention Arm,Intervention "Polymalt F(Iron Polymaltose Complex with folic acid)"
Postpartum women with normal hemoglobin levels who will receive intervention with iron supplements" Polymalt F (Iron Polymaltose Complex with folic acid)"1 daily orally for 6 week
Participants in the intervention group will receive drug Polymalt F (iron polymaltose complex with folic acid), one tablet orally once daily for 6 weeks after delivery. The purpose of this intervention is to evaluate whether routine iron supplementation helps prevent postpartum anemia in women with normal hemoglobin levels.
Andre navne:
  • iron supplements
Ingen indgriben: Control Arm,No iron supplements drug Polymalt F (polymaltose complex with folic acid)given group
This group of postpartum women with normal hemoglobin levels will not receive iron supplements

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in postpartum hemoglobin levels /development of postpartum anemia
Tidsramme: 6week
The primary outcome is to assess the effectiveness of routine iron supplementation in preventing postpartum anemia among women with normal hemoglobin levels. Hemoglobin levels will be measured at 6 weeks postpartum and compared between the iron supplementation group and the no iron supplementation group.
6week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Prof.Dr Sarah Jamil Khan, Consultant gynaecologist

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

15. oktober 2026

Studieafslutning (Anslået)

20. december 2026

Datoer for studieregistrering

Først indsendt

12. juli 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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