Clinical trial NCT03836703: Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women
Official title: Doubling the Iron Dose VS Single Dose Iron Supplementation to Prevent Iron Deficiency Anemia (IDA) in Twin Pregnant Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hematologic Pregnancy Complications
Keywords: Pregnancy, Twins , Iron Deficiency Anaemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements.

With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most.

Detailed description: Iron deficiency anemia (IDA) is a very prevalent condition in pregnancy, affecting nearly 18% of all pregnant women during all three trimesters, with as many as 29%of women affected during the third trimester.

In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. Thus, maternal hemoglobin (Hgb) in multiple pregnancies is lower in all trimesters compared with singleton gestations, with a rate of IDA estimated to be 2.4 to even 4 times higher.

Expert opinion relying on the increased risk for micronutrient deficiency in twin pregnancies recommends supplementation of iron beyond that contained in a typical prenatal vitamin. Moreover, some experts support doubling the dose of multivitamins containing 30 mg of elemental iron during the second and third trimesters of a twin pregnancy, regardless of maternal Hgb and ferritin concentrations.

With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most. The purpose of our study was to assess the efficacy of a single versus a double daily iron supplement dose in iron deficient women with twin pregnancies. Determining the effect of this intervention on maternal iron stores and immediate neonatal outcome measures will assist in defining evidence based recommendations for prenatal care.

Eligibility criteria: Inclusion Criteria:

* Twin pregnancy.
* Hemoglobin ≥ 10.5 gm/d l. at booking visit

Exclusion Criteria:

* Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation
* Thalassemia minor (alpha or beta).
* Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease, ulcerative colitis, previous bowel resection).
* Anemia from chronic illness.
* Any use of multi-vitamin supplements containing iron.
* Any chronic blood loss. e.g: hemorrhoids.
* Autoimmune disorders.

Primary outcomes:
measure: Hemoglobin level below 11 g/dl
timeFrame: 32 weeks gestation
measure: Hemoglobin level below 11 g/dl
timeFrame: 24 hours before delivery
Secondary outcomes:
measure: blood product administration
timeFrame: 24 hours after delivery
measure: GIT side effects
timeFrame: all over the pregnancy time 14 weeks gestation to delivery
measure: Preterm Birth
timeFrame: delivery before 37 weeks gestation
measure: neonatal Birth weidht
timeFrame: 5 min. after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abass
Study officials:
affiliation: AinShams U
name: Khaled Ibrahem, Prof
role: STUDY_CHAIR
References:
citation: Shinar S, Skornick-Rapaport A, Maslovitz S. Iron Supplementation in Twin Pregnancy - The Benefit of Doubling the Iron Dose in Iron Deficient Pregnant Women: A Randomized Controlled Trial. Twin Res Hum Genet. 2017 Oct;20(5):419-424. doi: 10.1017/thg.2017.43. Epub 2017 Aug 22.
citation: Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.