Fundacin Universitaria Juan N.

Corpas
Semestre VIII Investigacin II
Angy Alejandra Barragn Ruiz
Leydy Lorena Bello Pez
Tatiana Benavides Gonzlez
__________________________________________________________________________________________________

TALLER # 2 INVESTIGACIN

PREGUNTA DE INVESTIGACIN:

Cul tratamiento es ms efectivo entre misoprostol y otros medicamentos para el cdigo

rojo en mujeres postparto en la clnica juan N. Corpas?

P Mujeres postparto en cdigo rojo de la clnica Juan N. Corpas

I Misoprostol
C Otros medicamentos
O El mejor medicamento es el misoprostol
T Estudio retrospectivo desde el ao 2014 - 2016

F Es factible puesto que en la Clinica Juan N. Corpas se encunetra informacin de las pacientes que han
padecido de codigo rojo.
I Es interesante ya que queremos prevenir muertes maternas investigando que tratamiento es mejor para ellas.
N Se encuentra gran cantidad de artculos cientficos en las bases de datos medicas que nos respaldan la
investigacin.
E Se recolectara informacin de la patologa y de las pacientes con los permisos establecidos por la clnica y
otros que se deban obtener.
R Es relevante porque aporta gran informacin en el mbito ginecoobstetrico en el tratamiento de las maternas
posparto que pueden padecer de cdigo rojo.
 TRUNCAR TERMINO
Search results 252.548
HEMORRAGIA*

Postpartum AND hemorrhage

Search results: 9.062
Postpartum haemorrhage AND
misoprostol Search results: 36

Postpartum haemorrhage NOT

OPERADORES BOOLEANOS
cesarean Search results: 6701

Postpartum OR hemorrhage
Search results: 436.609
MISOPROSTOL IN POSTPARTUM

hemorrhage postpartum [ALL]:

Search results 8052
Search results 8.588
HEMORRHAGE

hemorrhage postpartum [MH]:

Search results 5757

CALIFICADORES DE CAMPO

hemorrhage postpartum [MAJR]

Search results: 4.130

hemorrhage postpartum[TITL]
Search results: 2

hemorrhage postpartum [ALL]

AND red code search results: 3

REGLAS Y SINTAXIS

hemorrhage postpartum [MH]

AND red code search results : 3

clinical trial, 5 years, humans,

femate, MEDLINE: search
results: 138

LIMITES / LIMITS

clinical trial, 5 years, humans,

femate, MEDLINE NOT cesarean:
search results: 93
 Articulo 1

Titulo: Guidelines for management of critical bleeding in obstetric

Autores: Irita K, Inada E.

Fecha: Enero 2011

Abstract
Hemorrhage is the leading cause of maternal death. Pregnant woman can tolerate a larger
amount of blood loss than non-pregnant woman, but obstetric hemorrhage is characterized by
a high incidence of coagulopathy. The Japanese Society of Anesthesiologists and four related
academic societies published "Guidelines for management of critical bleeding in obstetrics" in
April 2010. The following points are emphasized in these guidelines. Firstly, the trend of the
shock index (heart rate/systolic blood pressure) is useful to evaluate the necessity for blood
transfusion. Secondly, coagulopathy should be evaluated in a timely manner and treated
promptly, when blood loss including amniotic fluid exceeds 2,000 ml. Thirdly, an urgency code
for hemorrhage should be introduced to facilitate communication among the related
personnel with communication between the delivery/operating room and blood transfusion
service. According to a triage tag in disaster medicine, code I or code red is an extreme
emergency: overt hemorrhagic shock or evident massive hemorrhage. If code I is declared by
the designated commander, transfusion of uncross-matched ABO-identical as well as ABO-
compatible, non-identical red blood cells should be considered, if time is short or ABO-
identical red blood cells are unavailable. The commander is selected from senior physicians of
the anesthesiology or the obstetric department, and is responsible for crisis management.
The major problems in crisis management are hesitation to declare an emergency and failure
of communication. Declaration of an emergency is also essential for calling supportive
medical personnel. To deal rapidly with critical bleeding, hospital actions to be taken should
be prepared, and simulation exercise should be performed to correct inappropriate actions
prior to an actual crisis. A systematic, not individual, approach is required to save the life of a
bleeding pregnant woman.

Articulo 2

Titulo: Validation of Code Red: a proposal for the treatment of obstetric hemorrhage

Autores: Vlez lvarez GA, Agudelo Jaramillo B, Gmez Dvila J, Zuleta Tobn JJ.

Fecha: Octubre 2013

Abstract
Evaluate the effect of scenario-based simulation training and management guidelines on the
prevention and treatment of obstetric hemorrhage.
METHODS:
This quasi-experimental before-and-after study measured the effect of an intervention that
used simulation scenarios, together with the delivery of reminders as part of the strategy, to
train health workers in the recognition and treatment of obstetric hemorrhage. The
intervention consisted of two one-day training sessions conducted six months apart. The
effect on patient management was evaluated by reviewing the patients' clinical histories 24
months before and 18 months after the intervention.
RESULTS:
In tests administered to the group of health workers who received the training, their median
grade increased from 55% correct answers before the training to 85% afterwards (P < 0,001).
Before the training, there were 124 cases of hemorrhage (2.1%), whereas after the
intervention the incidence fell to 86 (1.8%), representing a 16.5% decline (RR = 0.84; CI 95%
= 0.6-1.1). The use of oxytocin increased from 58.3% to 74.1% (RR = 3; CI 95% = 1.0-1.6)
and active monitoring during the immediate -puerperium rose from 5% to 36.5% (RR = 4; CI
95%: 3.0-18.1).
CONCLUSIONS:
The intervention increased the use of beneficial practices for the prevention and early
detection of hemorrhage, resulting in an improvement in the incidence of hemorrhage,
although it was not statistically significant. It is essential to use simulation training on a
regular basis, together with additional strategies adapted to local conditions and the
circumstances of the particular group

PMID: 24301735
Full text: http://ref.scielo.org/8ky8tt
 Articulo 3

Titulo: Effectiveness and safety of misoprostol distributed to antenatal women to prevent

postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial

Autores: Sam Ononge, Oona M. R. Campbell, Frank Kaharuza, James J. Lewis, Katherine
Fielding, and Florence Mirembe

Fecha: Noviembre 2016

Abstract
Background
Oral misoprostol, administered by trained health-workers is effective and safe for preventing
postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by
non-health workers, including task-shifting to pregnant women themselves. However, the use of
misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence
to support self-administration or leaving it in the hands of non-health workers. This study aimed
to determine if antenatally distributing misoprostol to pregnant women to self-administer at
home birth reduces PPH.
Methods
Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized
trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending
antenatal care were eligible. Women in the control-arm received the standard-of-care; while the
intervention-arm were offered 600mcg of misoprostol to swallow immediately after birth of baby,
when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal
haemoglobin (Hb) by 2g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at
the cluster level and we used a paired t-tests to assess whether the mean difference between
the control and intervention groups was statistically significant.
Results
97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and
intervention arms respectively. Two thousand fifty-seven of the participants were successfully
followed up and 271(13.2%) delivered outside a health facility. There was no significant
difference between the study group in number of women who received a uterotonic at birth
(control 80.4% vs intervention 91.4%, mean difference=-11.0%, 95% confidence interval [CI]
-25.7% to 3.6%, p=0.11). No woman took misoprostol before their babys birth. Shivering and
fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean
difference=-7.2%, 95%CI -11.1% to -3.7%), p=0.005). There was a slight, but non-significant,
reduction in the percentage of women with Hb drop 2g/dl from 18.5% in the control arm to
11.4% in the intervention arm (mean difference=7.1%, 95%CI -3.1% to 17.3%, p=0.14).
Similarly, there was no significant difference between the groups in the primary outcome in the
women who delivered at home (control 9.6% vs intervention 14.5%, mean difference -4.9; 95%
CI -12.7 to 2.9), p=0.17).
Conclusion
This study was unable to detect a significant reduction in PPH following the antenatal distribution
of misoprostol.
The study was registered with Pan-African Clinical
Electronic supplementary material
The online version of this article (doi:10.1186/s12884-015-0750-6) contains supplementary
material, which is available to authorized users.
Keywords: Acceptability, Antenatal distribution, Home births, Misoprostol, Postpartum
haemorrhage, Safety, Stepped-wedge cluster trial
 Articulo 4

Titulo: Oral misoprostol versus oxytocin in the management of third stage of labour

Autores: Saima Aziz, Sarah Kazi, Gulfishan Haq, Nargis Soomro

Fecha: Abril 2014

Abstract

Objectives: To compare oral misoprostol versus intramuscular oxytocin in the management of

third stage of labour.
Methods: The quasi-experimental study was conducted at the Obstetrics and Gynaecology Unit II,
Civil Hospital, Karachi, from June 20 to December 19, 2006. A total of 70 patients diagnosed in
active phase of labour who fulfilled the inclusion criteria were selected by non-probability
convenience sampling. These patients were divided into 2 groups of 35 patients each, for
Oxytocin (Group 1) and misoprostol (Group 2) .
Main and secondary outcome measures were analysed. SPSS 10 was used for statistical analysis.
Results: Average amount of blood loss(ml) was 267.14140.35 with Oxytocin versus
302.86160.4, with Misoprostol, this difference was statistically insignificant (p=0.236). Average
drop in haemoglobin concentration (g/dl) with Oxytocin was 1.550.38 vs 1.660.61 with
Misoprostol (p=0.684). Drop in haematocrit (%) was 4.180.64 with Oxytocin vs. 4.500.92 with
Misoprostol (p=0.133). There was also insignificant difference in duration of third stage of labour,
between oxytocin and Misoprostol groups (5.372.20 vs. 5.232.46, p=0.451) Shivering, in
Misoprostol group occured in n=11 (31.4%) vs n=3 (8.6%) with Oxytocin (p=0.017) and pyrexia
in n=6 (17.1%) with misoprostol vs n=0, with oxytocin (p=0.025) thus significantly higher in
misoprostol group.
Conclusion: There were no major differences in oral misoprostol and intramuscular oxytocin in
the management of third stage of labour.
Keywords: Postpartum haemorrhage, Third stage of labour, Active management of third
stage, Misoprostol, Oxytocic drugs. (JPMA 64: 428; 2014).

Articulo 5

Titulo: A randomized controlled trial of sublingual misoprostol and intramuscular oxytocin for
prevention of postpartum hemorrhage

Autores: G. Prema Priya & Latha Chaturvedula

Fecha: Mayo 2015

Abstract
Purpose
In India, two third of maternal deaths occur in rural areas where there is lack of transportation
facilities, lack of refrigeration to store the injectable uterotonic drug such as oxytocin, lack of
skilled personnel to administer them and lack of sterile syringes and needles. Hence, this study
was conceived to evaluate misoprostol as a safe, effective, easily administered non-parenteral
drug in the prevention of postpartum hemorrhage.
Methods
This study was conducted during the period from August 2012 to July 2014. Low risk women with
singleton pregnancy at term admitted for vaginal delivery were eligible for the study. A total of
500 women were randomized to two groups, 250 in each group, either to receive 400 mcg
misoprostol sublingually or 10 units oxytocin intramuscularly at the delivery of anterior shoulder.
Patient factors, labor parameters, blood loss and side effects were noted.
Results
The women in both the groups were well matched with respect to age, parity, gestational age
and labor parameters. There was statistical significance in the blood loss (p = 0.04) between the
two groups. The average blood loss was 70 ml in misoprostol group and 75 ml in oxytocin group.
Shivering was the statistically significant side effect (p = 0.004) in the misoprostol group and
nausea was the statistically significant side effect (p = 0.003) in the oxytocin group.
Conclusions
Sublingual misoprostol is as effective as intramuscular oxytocin as a prophylactic oxytocic in
the active management of third stage of labor for prevention of postpartum hemorrhage.

Articulo 6

Titulo: Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a

cluster-randomised non-inferiority community trial

Autores: S Raghavan,S Geller,S Miller,SS Goudar,H Anger,MC, Yadavannavar,R Dabash,SR Bidri,

MR Gudadinni,R Udgiri, AR Koch,MB Bellad,B Winikoff

Fecha: septiembre 2015

Abstract
Objective
To assess whether secondary prevention, which preemptively treats women with above-average
postpartum bleeding, is non-inferior to universal prophylaxis.
Design
A cluster-randomised non-inferiority community trial.
Setting
Health sub-centres and home deliveries in the Bijapur district of Karnataka, India.
Population
Women with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife
at home or sub-centre and who consented to be part of the study.
Methods
Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual
misoprostol administered to women with postpartum blood loss 350 ml or to universal
prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of
labour.
Main outcome measures
Postpartum haemoglobin 7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin,
postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of
the intervention.
Results
Misoprostol was administered to 99.7% of women as primary prevention. In secondary
prevention, 92 (4.7%) women had postpartum bleeding 350 ml, of which 90 (97.8%) received
misoprostol. The proportion of women with postpartum haemoglobin 7.8 g/dl was 5.9 and 8.8%
in secondary and primary prevention clusters, respectively [difference 2.9%, one-sided 95%
confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in
both groups. Shivering was more common in primary prevention clusters (P = 0.013).
Conclusion
Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal
prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention
could be a good alternative to universal prophylaxis as it medicates fewer women and is an
acceptable and feasible strategy at the community level.

Articulo 7

Titulo: The MamaMiso study of self-administered misoprostol to prevent bleeding after childbirth
in rural Uganda: a community-based, placebo-controlled randomised trial

Autores: Andrew D. Weeks, James Ditai, Sam Ononge, Brian Faragher, Laura J. Frye, Jill
Durocher, Florence M. Mirembe, Josaphat Byamugisha, Beverly Winikoff, and Zarko Alfirevic

Fecha: Septiembre 2015

Abstract:
Background
600 mcg of oral misoprostol reduces the incidence of postpartum haemorrhage (PPH), but in
previous research this medication has been administered by health workers. It is unclear whether
it is also safe and effective when self-administered by women.
Methods
This placebo-controlled, double-blind randomised trial enrolled consenting women of at least 34
weeks gestation, recruited over a 2-month period in Mbale District, Eastern Uganda. Participants
had their haemoglobin measured antenatally and were given either 600mcg misoprostol or
placebo to take home and use immediately after birth in the event of delivery at home. The
primary clinical outcome was the incidence of fall in haemoglobin of over 20 % in home births
followed-up within 5 days.
Results
748 women were randomised to either misoprostol (374) or placebo (374). Of those enrolled, 57
% delivered at a health facility and 43 % delivered at home. 82 % of all medicine packs were
retrieved at postnatal follow-up and 97 % of women delivering at home reported self-
administration of the medicine. Two women in the misoprostol group took the study medication
antenatally without adverse effects. There was no significant difference between the study
groups in the drop of maternal haemoglobin by >20 % (misoprostol 9.4 % vs placebo 7.5 %, risk
ratio 1.11, 95 % confidence interval 0.717 to 1.719). There was significantly more fever and
shivering in the misoprostol group, but women found the medication highly acceptable.
Conclusions
This study has shown that antenatally distributed, self-administered misoprostol can be
appropriately taken by study participants. The rarity of the primary outcome means that a very
large sample size would be required to demonstrate clinical effectiveness.

Articulo 8

Titulo: Effectiveness and safety of misoprostol distributed to antenatal women to prevent

postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial

Autores: Sam Ononge, Oona M. R. Campbell, Frank Kaharuza, James J. Lewis, Katherine Fielding,
and Florence Mirembe

Fecha: Noviembre 2015

Abstract
Background
Oral misoprostol, administered by trained health-workers is effective and safe for preventing
postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by
non-health workers, including task-shifting to pregnant women themselves. However, the use of
misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence
to support self-administration or leaving it in the hands of non-health workers. This study aimed
to determine if antenatally distributing misoprostol to pregnant women to self-administer at
home birth reduces PPH.
Methods
Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized
trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending
antenatal care were eligible. Women in the control-arm received the standard-of-care; while the
intervention-arm were offered 600mcg of misoprostol to swallow immediately after birth of baby,
when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal
haemoglobin (Hb) by 2g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at
the cluster level and we used a paired t-tests to assess whether the mean difference between
the control and intervention groups was statistically significant.
Results
97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and
intervention arms respectively. Two thousand fifty-seven of the participants were successfully
followed up and 271(13.2%) delivered outside a health facility. There was no significant
difference between the study group in number of women who received a uterotonic at birth
(control 80.4% vs intervention 91.4%, mean difference=-11.0%, 95% confidence interval [CI]
-25.7% to 3.6%, p=0.11). No woman took misoprostol before their babys birth. Shivering and
fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean
difference=-7.2%, 95%CI -11.1% to -3.7%), p=0.005). There was a slight, but non-significant,
reduction in the percentage of women with Hb drop 2g/dl from 18.5% in the control arm to
11.4% in the intervention arm (mean difference=7.1%, 95%CI -3.1% to 17.3%, p=0.14).
Similarly, there was no significant difference between the groups in the primary outcome in the
women who delivered at home (control 9.6% vs intervention 14.5%, mean difference -4.9; 95%
CI -12.7 to 2.9), p=0.17).
Conclusion
This study was unable to detect a significant reduction in PPH following the antenatal distribution
of misoprostol.

Articulo 9

Titulo: Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for
prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled
trial
Autores: Ayisha Diop, Bocar Daff, Maimouna Sow, Jennifer Blum, Mamadou Diagne, Nancy L
Sloan, Beverly Winikoff
Fecha: Enero 2016
Abstract
background
Access to injectable uterotonics for management of postpartum haemorrhage remains limited in
Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been
deemed viable alternatives in community settings. We aimed to compare the efficacy of these
drugs when delivered by auxiliary midwives at maternity huts.
Methods
We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in
Senegal. Maternity huts with auxiliary midwives located 321 km from the closest referral centre
were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity
Health Projects) to either 600 g oral misoprostol or 10 IU oxytocin in Uniject (intramuscular),
stratified by reported previous year clinic volume (deliveries) and geographical location (inland or
coastal). Maternity huts that had been included in a previous study of misoprostol for prevention
of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their
third trimester were screened for eligibility either during community outreach or at home-based
prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were
eligible for the study. Women with known allergies to prostaglandins or pregnancy complications
were excluded. The primary outcome was mean change in haemoglobin concentration measured
during the third trimester and after delivery. This study was registered with ClinicalTrials.gov,
number NCT01713153.
Findings
28 maternity hut clusters were randomly assigned14 to the misoprostol group and 14 to the
oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647
women in the misoprostol group and 402 in the oxytocin group received study drug and had
recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women
delivered in the study maternity huts. The mean change in haemoglobin concentrations was 35
g/L (SD 161) in the misoprostol group and 27 g/L (SD 178) in the oxytocin group. When
adjusted for cluster design, the mean difference in haemoglobin decreases between groups was
not significant (03 g/L, 95% CI 826 to 892, p=071). Both drugs were well tolerated. Shivering
was common in the misoprostol group, and nausea in the oxytocin group. Postpartum
haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and
transferred to a higher-level facility for additional care, and fully recovered. No other women
were transferred.

Articulo 10
Titulo: Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a
cluster-randomised non-inferiority community trial

Autor S Raghavan, S Geller, S Miller, SS Goudar,H Anger,MC Yadavannavar,R Dabash,SR Bidri,MR

Gudadi, R Udgiri,AR Koch,MB Bellad,B Winikoff
Fecha Septiembre 2015

Abstract
Objective
To assess whether secondary prevention, which preemptively treats women with above-average
postpartum bleeding, is non-inferior to universal prophylaxis.
Design
A cluster-randomised non-inferiority community trial.
Setting
Health sub-centres and home deliveries in the Bijapur district of Karnataka, India.
Population
Women with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife
at home or sub-centre and who consented to be part of the study.
Methods
Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual
misoprostol administered to women with postpartum blood loss 350 ml or to universal
prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of
labour.
Main outcome measures
Postpartum haemoglobin 7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin,
postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of
the intervention.
Results
Misoprostol was administered to 99.7% of women as primary prevention. In secondary
prevention, 92 (4.7%) women had postpartum bleeding 350 ml, of which 90 (97.8%) received
misoprostol. The proportion of women with postpartum haemoglobin 7.8 g/dl was 5.9 and 8.8%
in secondary and primary prevention clusters, respectively [difference 2.9%, one-sided 95%
confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in
both groups. Shivering was more common in primary prevention clusters (P = 0.013).