Title of Guideline (must include the word “Guideline” (not protocol, Guideline for the Administration

policy, procedure etc) of Anti-D

Author: Contact Name and Job Title Jane Pidgeon Supervisor of Midwives
Linda Hoyland Blood Bank Manager

Directorate & Speciality Family Health

Obstetrics
Date of submission December 2015 amended August
2017
Explicit definition of patient group to which it applies (e.g. inclusion All women who have a Rhesus (RH)
and exclusion criteria, diagnosis) negative blood group

Version 4

If this version supersedes another clinical guideline please be Replaces version 3

explicit about which guideline it replaces including version number.
Statement of the evidence base of the guideline – has the Evidence from NICE guidance
guideline been peer reviewed by colleagues? and British Blood Transfusion
Evidence base: (1-6)
Society
1 NICE Guidance, Royal College Guideline, SIGN
(please state which source).
2a meta analysis of randomised controlled trials
2b at least one randomised controlled trial
3a at least one well-designed controlled study without
randomisation
3b at least one other type of well-designed quasi-
experimental study
4 well –designed non-experimental descriptive
studies (ie comparative / correlation and case
studies)
5 expert committee reports or opinions and / or
clinical experiences of respected authorities
6 recommended best practise based on the clinical
experience of the guideline developer
Consultation Process Midwives, Obstetricians, Nottingham
Guideline Development Group, Blood
Transfusion Practitioners
Ratified by: Maternity Guidelines Group

Date:
Target audience Midwives and/or obstetricians
notifying maternal death

Review Date: (to be applied by the Integrated Governance Team) 01/12/2020

A review date of 5 years will be applied by the Trust. Directorates
can choose to apply a shorter review date, however this must be
managed through Directorate Governance processes.

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This guideline has been registered with the trust. However, clinical guidelines are guidelines only.
The interpretation and application of clinical guidelines will remain the responsibility of the
individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using
guidelines after the review date.

Guideline for the Administration of Anti-D Immunoglobulin

Introduction

Anti-D immunoglobulin (Ig) is available to prevent a rhesus (Rh) negative

mother from forming antibodies to fetal rhesus positive cells, which may
pass into the maternal circulation. It is recommended that routine
antenatal Anti-D prophylaxis (RAADP) be offered to all non-sensitised
pregnant women who are Rh negative (NICE, 2008). However, it cannot
prevent all instances of sensitisation, some of which occur either despite
or before appropriate administration of Anti-D (Chilcott et al, 2003).

Objective

The objective is to protect any subsequent child from the risks of

haemolytic disease of the newborn.

Consent

The clinician (midwife, obstetrician or general practitioner (GP))

responsible for the antenatal care of a non-sensitised Rh negative
woman should discuss with her RAADP and the options available so that
the woman can make an informed choice about treatment.
All discussions must be documented in the hand held records.
The difference between RAADP (i.e. routine prophylaxis at 28 weeks)
and prophylactic Anti-D Ig given because of likely sensitisation should be
clearly explained to the woman (NICE, 2008).
In view of the theoretical risk of new variant CJD posed by UK plasma all
anti-D produced is now manufactured from US plasma and screened for
HIV and Hepatitis B and C (risk<1 in a million). Because of the potential
risks posed by any human derived plasma product it is important to
maintain traceability of all products given.

Women should be informed that occasionally Anti-D prophylaxis causes

allergic responses in the mother, but these are rare.

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Women who might decline blood products should be made aware that
Anti-D is made from blood products.

Management

1 Routine Antenatal Anti-D Prophylaxis (RAADP)

Anti-D immunoglobulin (Ig) should be administered routinely to all non-

sensitised Rh negative women at 28 weeks of pregnancy according to
NICE guidance.
Women should still receive their RAADP at 28 weeks of pregnancy even
if she has had previous doses of Anti-D for a sensitising event (E.g. PV
bleed, or trauma to the abdomen)
 For women whose bloods are sent to Derby, Leicester or Lincoln,
the midwife must ensure that a copy of the blood result is sent to
the hospital that the woman is booking at, in order for blood bank
to be able to identify these women.
 Women must be given sufficient information to enable them to
make an informed choice, once they have been identified as being
rhesus negative.
 When the midwife sees the woman at the 15+ to 18 week
appointment, the blood results must be documented in the hand
held records and the paper copy filed at the back. An information
leaflet must be given to the woman.
 The woman’s blood group will be checked against the booking
sample by the laboratory staff.
 The midwife should generate a 28 week appointment at the clinic
when the woman is seen at the 15+ to 18 week appointment.
 The midwife should complete a request form for routine doses of
Anti-D at the 15+ to 18 week appointment, and send to blood bank.
The form should state where the Anti-D needs to be sent (which
community clinic or hospital clinic if the woman is due to have her
28 week appointment there). If the appointment is due to be at the
hospital the midwife must inform the antenatal clinic so that the
details can be recorded in their diary to ensure the Anti-d gets
collected in time for the appointment.
 The midwife should contact blood bank if the woman miscarries,
moves out of the area or delivers early.

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  At the 28 week appointment the midwife will take further blood
tests for antibody testing before administering the routine Anti-D Ig
(checking name, DOB, batch number and expiry date). A dose of
1500IU is given at this time. The small sticker with the batch
number should be secured in the Part 1 records next to the
documentation of the Anti-D being administered.
 The midwife should complete both copies of the form from blood
bank and file one copy in the client held records and return the
other copy to blood bank to maintain product traceability.
If the woman is having her antenatal care at the hospital at 28 weeks the
Anti-D Ig can be given there.
Women from Grantham, Newark, Lincoln, Loughborough and Leicester
will attend the NUH antenatal clinic to have their routine 28 week Anti-D
prophylaxis.

Administration

The Anti-D Ig should be given into the deltoid muscle for maximum
absorption (RCOG, 2002).

Reactions are rare, but do occur. For this reason the woman must have
baseline observations including pulse rate, blood pressure and
temperature recorded before the injection is given and the woman
should be monitored for at least 20 minutes after administration of the
injection for signs and symptoms of allergy and anaphylaxis. These
include generalised urticaria, tightness of chest, wheezing and
hypotension. If the patient starts to feel unwell while this medicine is
being injected, then the injection must be stopped immediately.
Administer appropriate medical care/medication.

A SHOCK BOX/ANAPHYLAXIS KIT SHOULD ALWAYS BE

AVAILABLE WHEN ADMINISTERING ANTI D Ig IN CASE OF ANY
ADVERSE REACTIONS.

Any such occurrences must be reported to the Blood Transfusion

Laboratory / Blood Products Laboratory (BPL).

For sensitised women

This guideline does not apply to women found to be sensitised (has

produced Anti-D herself) or has any other antibodies present. They will
require monitoring/management through consultant led clinics and the
blood transfusion centre. Refer these women for consultant led care
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through the fetal medicine clinic / fetal care. If the Anti-D titre is <1.0
IU/ml Anti-D prophylaxis may still be appropriate to help prevent the titre
rising.
Women who have become sensitised where prophylaxis has failed need
to be referred to the feto-maternal clinic.

Storage

Anti-D will arrive at the GP Surgery or community centre with a

confirmation receipt attached to the envelope or transport bag. The
person taking receipt should complete this slip and return it to the
issuing Blood Transfusion Laboratory. The Anti-D should then be placed
in the designated temperature controlled clinical drug refrigerator( NUH
medicines code of practice-storage and security of medicines, controlled
documentation, and medicine keys on wards and departments). The
use of a log book to record the receipt and administration or return of
Anti-D can assist in stock control and traceability. Midwives should
check the content of the refrigerator on a weekly basis to ensure the
Anti-D is still required and in date. Any unwanted or expired Anti-D
should be returned to the Blood Transfusion Laboratory.
Anti-D must be stored between 2-8oC. It is important that the Anti-D
should be stored in the fridge upon receipt to ensure the integrity and
efficacy of the product is maintained. If fridge storage is not available then
Anti-D can be kept at room temperature (up to 25oC) for no more than 1
week, this includes transit time. The product must NOT be frozen. The GP
surgery or community centre manager, or appointed practitioner in charge
of midwifery at the location is responsible for ensuring the Anti-D is
recorded and stored appropriately.
Inform the issuing Blood Transfusion Laboratory if Anti-D has been stored
outside the recommended temperature.

2 Antenatal Anti-D Prophylaxis (AADP)

Anti-D Ig should be given to all non-sensitised Rh negative women after

the following potentially sensitising events during pregnancy:

Prophylaxis following pregnancy loss

 Therapeutic termination of pregnancy (NICE, 2008,RCOG,2011).
 Ectopic pregnancy and molar pregnancy (NICE, 2008,
RCOG,2011).
 Spontaneous miscarriage after 12 weeks of pregnancy (NICE,
2002, Grade B recommendation),

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  Medical management of miscarriage as Misoprostol can initiate
more than natural uterine contractions.
 After curettage to remove products of conception. It is not required
when there has been no instrumentation to evacuate the products
of conception (NICE, 2002).
 Threatened miscarriage after 12 weeks of pregnancy. When
bleeding continues intermittently after 12 weeks gestation, Anti-D
Ig should be given at 6 weekly intervals (NICE, 2002). A kleihauer
test should be carried out at 2 weekly intervals. In this situation
non-invasive fetal RHD typing using maternal plasma could be
considered to reduce hospital attendance, blood sampling and
avoid repeated administration of Anti-D. Advice can be sought
though the fetal medicine/fetal care unit regarding this testing.
 It is prudent to administer Anti-D Ig where bleeding is heavy or
repeated or where there is associated abdominal pain particularly
if these events occur as gestation approaches 12 weeks (NICE,
2002). In such cases the gestation will be confirmed by ultrasound
(RCOG, 2002) on the early pregnancy unit.
Prophylaxis following sensitising events before delivery
 Invasive prenatal diagnosis (amniocentesis, chorion villus
sampling, fetal sampling)
 Other intrauterine procedures (e.g. insertion of shunts, embryo
reduction)
 Antepartum haemorrhage
 External cephalic version of the fetus
 Closed abdominal injury
 Intrauterine death (RCOG, 2002)-see Guidelines for pregnancy
loss in the first and second trimester

A dose of 500IU is recommended for prophylaxis following sensitising

events at any gestation of pregnancy. The exact amount will be
determined through a Kleihauer test.
Additional dose(s) of Anti-D will be necessary if the volume of
fetomaternal haemorrhage exceeds that covered by the standard Anti-D
Ig dose (>4mls). A follow up kleihauer will be required. The timing of the
kleihauer will be determined by the laboratory.
For successful immunoprophylaxis, Anti-D Ig should be given as soon as
possible after the sensitising event but always within 72 hours. If it is not
given before 72 hours every effort should still be made to administer the
Anti-D Ig, as a dose within 9-10 days may provide some protection
(NICE, 2002). Any dose given after 72 hours should be reported to
Blood Bank using the appropriate incident reporting procedure. All

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incidents involving Anti-D prophylaxis must be reported to the Serious
Hazards of Transfusion (SHOT) – please inform the Blood Bank
laboratory who will report to SHOT.

Cell Salvage

Where intra-operative cell salvage is used during caesarean section in D

negative, previously non-sensitised women, and where cord blood group
is confirmed as D positive (or unknown), a minimum dose of 1500IU
should be administered following the re-infusion of salvaged red cells,
and a maternal sample should be taken for estimation of fetomaternal
haemorrhage 30-45 minutes after reinfusion in case more Anti-D Ig is
indicated. It is important that clinicians inform the transfusion laboratory
to ensure that the correct dose of Anti-D is issued (NICE, 2008)

Women
Womenwho
whoare
arealready
alreadysensitised
sensitisedshould
shouldnot
notbe
begiven
givenAnti-D
Anti-DIg.
Ig

Post Delivery

At least 500IU of Anti-D Ig must be given to every non-sensitised Rh

negative woman within 72 hours following the delivery of a rhesus
positive infant (NICE, 2002). If for any reason a sample is not obtained
from the infant post -delivery then the baby’s group should be taken as
Rh D positive and Anti-D Ig given as normal based on the Kleihauer
result.
Women with other blood group antibodies (alloantibodies) other than
Anti-D still require their Anti-D
A Kleihauer will be taken from the mother and placenta/infant after
delivery to detect any fetomaternal haemorrhage greater than 4ml so
that additional Anti-D Ig can be given as appropriate (NICE, 2002).

References

British Blood Transfusion Society (2013) BCSH guideline for the use of
Anti-D immunoglobulin for the prevention of haemolytic disease of the
fetus and newborn.

Chilcott,J:Lloyd
Jones,M;Wight,J;Forman,K;Wray,J;Beverley,C;Tappenden,P (2003) A

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review of the clinical effectiveness and cost-effectiveness of routine anti-
D prophylaxis for pregnant women who are rhesus negative. Health
Technology Assessment NHS R+D HTA Programme.

National Institute for Clinical Excellence (2002) Full Guidance on the use
of routine antenatal anti-D prophylaxis for rhesus negative women
(HTML).

National Institute for Clinical Excellence (2008) Routine Antenatal Anti-D

Prophylaxis for Women who are Rhesus negative. NICE Technology
Appraisal Guidance 156.

National Institute for Clinical Excellence Technology Assessment Report

(TAR) Feb 2009. Routine Antenatal Anti-D Prophylaxis for RhD-negative
women:A systematic review and economic evaluation (Squires). Vol 13,
No 10.

Royal College of Obstetricians and Gynaecologists (2002) Clinical green

top guidelines. Use of anti-D immunoglobulin for rhesus prophylaxis
(22)-now archived.

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