CLINICAL PRACTICE PROTOCOL

Rh D Immunoglobulin Administration (Formerly Anti D)
SCOPE (Area): Acute
SCOPE (Staff): Medical, Nursing, Midwifery
Printed versions of this document SHOULD NOT be considered up to date / current


Rationale

Rh D blood group incompatibility between an Rh D negative woman and her Rh D positive infant may cause alloimmunisation against the Rh D antigen. A sensitised woman may develop immune anti-D, which binds to fetal Rh D positive blood cells and destroys them which can result in haemolytic disease of the newborn (HDN). HDN can have devastating effects for the fetus and the newborn baby in addition to implications for subsequent pregnancies leading to further morbidity and mortality.


Expected Objectives / Outcome

  • To administer Rh D immunoglobulin (RhD-Ig) to non sensitized Rh D negative women in a timely manner so the risk of maternal sensitization to fetal Rh D positive red blood cells is reduced.


Definitions

Rh D: Along with four main blood groups (A, B, AB, & O), there are also Rhesus (Rh) antigen groups. The three main groups are D, C/c, and E/e. When a person has the Rh D then they are classified as Rh positive. Eighty-five percent of the populations are Rh positive and the other fifteen percent do not have Rh D and are Rh negative. When an Rh negative women has a partner who is Rh positive there is a good chance that their baby will be Rh positive. If an event occurs which causes fetal blood to mix with maternal blood the mother may develop antibodies against the babys blood. These antibodies cross the placenta and may damage the fetus red blood cells. This may lead to the development of haemolytic disease in the fetus / newborn. Women who are Rh negative and have a partner who is Rh negative or women who are Rh positive are not at risk of developing these antibodies.

Rh D Ig: acts by suppressing the immune response in Rh negative individuals who are exposed to Rh D positive red cells, thus preventing the development of antibodies to Rh D.

Alloimmunisation: development of antibodies by an individual in response to a component of the tissues of another individual of the same species.

Haemolytic Disease: occurs when the babys red blood cells are destroyed more rapidly than normal. When Rh D alloimmunisation occurs, the antibodies produced by the mother target and destroy foreign red blood cells from an Rh D positive baby. Haemolytic disease can lead to anaemia, jaundice, kernicterus and death.

Antibody screen: A blood test that detects antibodies in the blood. Also known as an indirect antiglobulin test (IAT) or an Indirect Coombes.

Kleihauer Test: A blood test which detects the presence and amount of fetal cells in the maternal blood.

Fetomaternal haemorrhage (FMH): Where transplacental passage of fetal blood into the circulation of the mother occurs.

Key Points:

  • The administration of RhD-Ig to Rh(D) Negative women with no immune anti-D antibodies, results in a significant reduction in the incidence of RhD isoimmunisation.

  • A Kleihauer test is not required in the first trimester.

  • All women with second and third trimester sensitising events or postpartum indications for RhD-Ig should have the magnitude of the FMH assessed via Kleihauer Test estimation. This will determine the dose of RhD-Ig required.

  • The Consent and Administration form MR/056.1 Must be completed before administration of Rh D-Ig 

  • If a woman refuses RhD-Ig document the reason on the Consent and Administration RhD Immunisation  MR/056.1

  • RhD-Ig can interfere with response to live vaccines, administration of such vaccines including poliomyelitis and measles should occur 3 months after RhD-Ig administration


Indications

Please refer to both care pathway attached in references for the prophylactic use of Rh D immunoglobulin in pregnancy inclusive and exclusive of non-invasive prenatal testing

INDICATIONS FOR THE USE OF Rh D IMMUNOGLOBULIN

ANTEPARTUM (Sensitising Events)

 

First Trimester Indications (prior to and including 12 weeks gestation)

 

     Miscarriage.

 

     Termination of pregnancy (medical or surgical).

 

     Ectopic pregnancy.

 

     Chorionic villus sampling (CVS).

Administration

 

  • One mini dose of 250 International Units (IU) RhD-Ig is sufficient to cover a foetal maternal haemorrhage (FMH) of 2.5 mL of foetal red blood cells. To ensure adequate protection against immunisation this dose should be offered to all Rh D negative women who have indications for RhD-Ig and have no pre-existing immune anti D.

  • For recurrent bleeds in an ongoing pregnancy, this dose will be effective for a period of 6 weeks up to and including 12 weeks gestation.

  • A subsequent miscarriage or a procedure requiring instrumentation of the uterus requires an additional dose of RhD-Ig irrespective of when the first dose was given.

  • A Kleihauer test is not required in the first trimester as one 250 IU Mini-dose RhD-Ig will be sufficient for single pregnancies (as the total blood volume of the fetus is <2.5mL).

  • For multiple pregnancy 625 IU RhD-Ig should be given.

  • There is insufficient evidence to suggest that a threatened miscarriage before 12 weeks gestation necessitates Anti D administration.

Second and Third Trimester Indications (13 weeks or greater gestation)

 

     Amniocentesis and cordocentesis.

 

     Ectopic pregnancy.

 

     Foetal death.

 

     Threatened, incomplete or spontaneous abortion or termination of pregnancy.

 

     Abdominal trauma considered sufficient to cause fetomaternal haemorrhage (FMH) (e.g. motor vehicle accident).

 

     Antepartum haemorrhage (revealed or concealed)

 

     External cephalic version (successful or unsuccessful)

Administration

 

  • A Kleihauer test should be performed after each sensitising event so that pathology can determine the dose of RhD-Ig required.  The sample should be collected 30 min after the event, procedure or birth of the infant and before one hour.

  • Kleihauer tests may be collected up to 72 hours after the event but increases the risk that additional doses of RhD-Ig needed for large FMH will not be administered within the required 72 hours.

  • 625 IU RhD-Ig is required as soon as possible after a sensitising event whilst awaiting the impending Kleihauer result.  The Kleihauer result will determine if an additional RhD-Ig dose is required.

ANTEPARTUM (Prophylaxis)

Antenatal Booking / First Visit:

  • At the first visit, current group and antibody screen results are required on ALL pregnant women, regardless of blood type and are to be noted in the Birthing Outcomes System (BOS).

  • If a copy of this report is not available at the womans first antenatal visit, a blood group and antibodies screen is ordered.

  • Provide pamphlet You & Your Baby Important Information for Rh (D) Negative Women

28 Weeks Gestation

  • Rh(D) negative women should attend antenatal clinic at 28 weeks gestation for prophylaxis administration of RhD-Ig 625IU

  • Antibody screen results are required within seven days prior to administration of  RhD-Ig

  • A copy of the report is to be checked by two midwives

  • If the womans results are unavailable an antibody screen is requested

  • The pathology request must include: All relevant information including previous history of transfusion, previous history of antibodies and gestation, dates of any prophylactic RhD-Ig administered in the last 3 months

  • Upon checking the result, RhD-Ig 625IU may be administered.

34 Weeks Gestation:

  • Women are administered a second dose of RhD-Ig 625IU at 34 weeks gestation

  • Dose not to be given within six weeks of each other

  • No antibody screen is required

If an antenatal prophylactic dose is missed it should be given as soon as possible.  The second dose should then be delayed until six weeks after the initial dose.

Administration

  •  Order for Rh D-Ig to be checked on Medication Chart MR/700.2

  • Ensure written consent is obtained prior to administration of Rh D-Ig.  An explanation of the risks and benefits of receiving the product and why it is required must be given. Document administration in  Birthing Outcomes (BOS) and on the Rh D Immunoglobulin Patient Consent and Administration Form MR 056.1

  • Obtain RhD-Ig from drug room fridge or from Pharmacy for other departments.

  • Complete documentation in RhD-Ig register (Maternity only)

  • Ensure two Registered Nurses/Midwives check order, blood group results, medication and mothers details prior to administration.

  • Prepare and administer intramuscular injection into the deltoid or the anterolateral thigh.

 

Blood Group and antibodies screen required on admission to the Labour Ward if:

  • atypical red cell antibodies are present,

  •  the womans serological history is unknown,

  •  prophylactic RhD-Ig has been given,

  •  there is increased risk of requiring a blood transfusion.

POSTPARTUM

Maternal Sample

 

     All Rh D negative women with an Rh D positive infant should have a Kleihauer test (an estimate of feto-maternal haemorrhage) to determine the need for additional doses of RhD-Ig.

 

     The presence of residual RhD-Ig from antepartum administration of RhD-Ig does not indicate on-going protection.

Cord Sample

 

    A cord blood sample (3 mls) should be taken from all babies of Rh D negative women, women with known antibodies and in cases where there is insufficient documentation of maternal blood group or antibody status.

 

    The cord sample should be tested for blood group and direct antiglobulin test (DAT also known as Coombs test). If DAT positive haemoglobin and bilirubin estimation should also be performed.

 

     The cord blood sample should be labelled as baby of mothers name with the infants date and time of birth and gender.  The infants number should be added if available. (As well as the infants details place a mothers bradma with the mothers details on the pathology request form).  As with all blood bank samples, sign the tube and the request form to indicate positive identification of the sample and baby.

Administration

 

  • All Rh D negative women who have an Rh D positive infant should have 625 IU RhD-Ig within 72 hours of birth.

  • Increased dosing will be determined by the haematologist depending on the Kleihauer result.

 


Issues To Consider

Precautions

 
  • Women with an IgA deficiency
  • Women with a blood disorder or bleeding problems.
  • Women who have had a vaccination in the last two weeks.
  • Women with allergies to any medications.

When a woman has a BMI >30

  • The Blood Service/CSL Rh(D) immunoglobulin must be given by deep intramuscular injection. For women with a BMI >30, particular consideration should be given to factors which may impact on the adequacy of the injection, including the site of administration and the length of the needle used.
  • No specific additional testing is required because a woman has a BMI >30. Routine post-administration testing is not required unless there has been a large fetomaternal haemorrhage (FMH); in which case, testing should be in accordance with current established guidelines.
  • For women with a BMI >30 who experience a FMH of greater than 6mL, consideration may be given to administering any required additional doses of Rh(D) immunoglobulin via the intravenous route to increase bio-availability and facilitate the more rapid clearance of fetal cells.
Dosing
 
  • If a dosage greater than 5mL is required it is recommended that a divided dose be given at different sites.
  • For large bleeds it is recommended that antibody screening and Kleihauer be performed on a sample of maternal blood collected at 48 hours following RhD-Ig administration.  This will determine if further dosing is required.  Supplemental RhD-Ig should be given if the Kleihauer is positive and no antibodies are detected.
  • A single dose of RhD-Ig should not be withheld based upon pending results of the Kleihauer.
  • RhD-Ig should not be given to women with preformed antibodies except when due to antenatal administration of Rh D-Ig.
Half Life
The half life of Rh D immunoglobulin is approximately 3-4 weeks. It can be detected in a patient’s serum up to six weeks after administration. This time span would be shortened with ongoing bleeds
RhD-Ig and Vaccinations
Administration of RhD-Ig and MMR/Rubella vaccine (or any other live attenuated vaccine) may be compromised if;
 →   RhD-Ig is given within 2 weeks after MMR/Rubella vaccine.
 →   RhD-Ig and MMR/Rubella vaccine are given at same time (in different sites).
 →   MMR/Rubella vaccine is given within 3 months of RhD-Ig administration.

It is recommended that the patient’s GP is alerted, to test for seroconversion for MMR/Rubella two months after vaccination and re-vaccinate the patient if necessary.

Possible side effects
Maternal
 
  • Local tenderness, erythema, or stiffness at site of injection, should resolve in a few hours.
  • Occasional temperature, malaise, drowsiness, urticaria or hives (rare).
  • A rare but possible risk of transmission of blood borne disease.  (Anti-D has been used in Australia for 30 years with no reports of transmission of infection via this route).,
  • Remote chance of idiosyncratic or anaphylactoid reaction.
  • For further information please refer to product statements.
Foetal/Neonatal
  • No evidence of any harm to baby.
  • It is considered safe to breastfeed following administration of RhD-Ig.
 


Equipment

→    Medication order for Rh D immunoglobulin written→    23 &19g needle
on Rh D Immunoglobulin Patient Consent and→    Alcohol swab
Administration Form MR 056.1(Appendix 1 )→    Sharps container
 →    3ml syringe
→    Dose of Rh D immunoglobulin ordered→    Gloves

 


Detailed Steps, Procedures and Actions

  • Order for Rh D-Ig to be checked  on Medication Chart  MR /7000.2

  • Ensure written consent is obtained prior to administration of Rh D-Ig.  An explanation of the risks and benefits of receiving the product and why it is required must be given.

  • Obtain RhD-Ig from postnatal drug room fridge if for use in the Maternity Unit or from Pharmacy for other departments.

  • Complete documentation in RhD-Ig register located near the postnatal drug fridge (Maternity only).

  • Ensure two Registered Midwives check order, blood group results, medication and mothers details prior to administration.

  • Prepare and administer intramuscular injection into the deltoid or the anterolateral thigh.

  • Document administration in patients BOS notes and on the Rh D Immunoglobulin Patient Consent and Administration Form MR 056.1.

Dosage for RhD-Ig:

 Routine Prophylaxis beyond Week 12 and post partum

625 IU

Sensitising Events

Single pregnancy

Multiple Pregnancy

First trimester

250 IU

625 IU

Second and third trimester

625 IU

625 IU

Routine prophylaxis at 28-30 and 34-36 weeks

625 IU

625 IU

Postpartum

625 IU

625 IU

Rh(D) positive platelets given to a RhD negative patient

 

250 IU


Related Documents

SOP0001 - Principles Of Clinical Care


References

ACSQHC. (2019). The National Safety and Qualify Health Service (NSQHS) Standards - Blood Management Standard. Retrieved from
Australian Red Cross Blood Service. (2014). Prevention of haemolytic disease of the newborn - important information for RH(d) negative women. Retrieved from
National Blood Authority. (201?). Care pathway for the prophylactic use of Rh D immunoglobulin in pregnancy care (including NIPT). Retrieved from
National Blood Authority. (202?). Guideline for the prophylactic use of Rh D immunoglobulin in pregnancy care - summary of recommendations and expert opinions. Retrieved from
National Blood Authority. (2021). Prophylactic use of Rh D immunoglobulin in pregnancy care. Retrieved from
RANZCOG. (2019). Guidelines for the use of Rh (D) Immunoglobulin (Anti-D) in Obstetrics. Retrieved from


Appendix

MR056.1 Rh D Ig Consent and Administration
Prophylactic use of RhD immunoglobulin for RhD negative women



Reg Authority: Clinical Online Ratification Group Date Effective: 11/07/2022
Review Responsibility: NUM Maternity Outpatients Date for Review: 30/09/2024
Rh D Immunoglobulin Administration (Formerly Anti D) - CPP0425 - Version: 8 - (Generated On: 26-04-2025 05:45)